Specialty Appliances, LLC
Cumming, GA, US
SPECIALTY APPLIANCES, LLC appears in FDA device records in Cumming, GA. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 10 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Specialty Appliances, LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Specialty Appliance Works, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 3 510(k) clearances for Specialty Appliances, LLC between 2007 and 2019. The busiest year on record is 2007, with 1. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2009 | 1 |
| 2019 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004158247 | 3004158247 | SPECIALTY APPLIANCES, LLC | 4905 HAMMOND INDUSTRIAL DRIVE, CUMMING, GA 30041 US | 2026 | and 8 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DYHAdhesive, Bracket And Tooth Conditioner, Resin
- NXCAligner, Sequential
- ECIBand, Elastic, Orthodontic
- ECMBand, Preformed, Orthodontic
- EJFBracket, Metal, Orthodontic
- EJLBur, Dental
- ECNClamp, Wire, Orthodontic
- ELZCrown, Preformed
- LRKDevice, Anti-Snoring
- EJBHandle, Instrument, Dental
- OATImplant, Endosseous, Orthodontic
- QJJIndirect Bonding Tray
- DZNInstruments, Dental Hand
- ELWMaterial, Impression
- ECSPusher, Band, Orthodontic
- DYJRetainer, Screw Expansion, Orthodontic
- DZDTube, Orthodontic
- EGDWax, Dental, Intraoral
- DZCWire, Orthodontic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1511-2015 | TS ROC Crown Component 4UR (5/pk), TS ROC Crown Component 5UR (5/pk), TS ROC Crown Component 6UR (5/pk), TS ROC Crown Component 7UR (5/pk), TS ROC Crown Component 8UR (5/pk), TS ROC Crown Component 4LR (5/pk), TS ROC Crown Component 5LR (5/pk), TS ROC Crown Component 6LR (5/pk), TS ROC Crown Component 7LR (5/pk), TS ROC Crown Component 8LR (5/pk), TS ROC Crown Component 4UL (5/pk), TS ROC Crown Component 5UL (5/pk), TS ROC Crown Component 6UL (5/pk), TS ROC Crown Component 7UL (5/pk), TS ROC Crown Component 8UL (5/pk), TS ROC Crown Component 4LL (5/pk), TS ROC Crown Component 5LL (5/pk), TS ROC Crown Component 6LL (5/pk), TS ROC Crown Component 7LL (5/pk), TS ROC Crown Component 8LL (5/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance. | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. | Class II | Terminated | |
| Z-1510-2015 | Upper Right Telescope Unibodies (5/pk) and Upper Left Telescope Unibodies (54/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance. | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. | Class II | Terminated | |
| Z-1509-2015 | TS Crown Component 4UR (5/pk), TS Crown Component 5UR (5/pk), TS Crown Component 6UR (5/pk), TS Crown Component 4LR (5/pk), TS Crown Component 5LR (5/pk), TS Crown Component 6LR (5/pk), TS Crown Component 4UL (5/pk), TS Crown Component 5UL (5/pk), TS Crown Component 4LL (5/pk), TS Crown Component 5LL (5/pk), and TS Crown Component 6LL (5/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. | Class II | Terminated | |
| Z-1508-2015 | LR Telescoping Cantilever Arms (5/pk) and LL Telescoping Cantilever Arms (5/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance. | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. | Class II | Terminated | |
| Z-1507-2015 | HTM Mechanism Set Set 16, HTH Mechanism Set Size 18, HTH Mechanism Set Size 21 and HTH Mechanism Set Size 24 A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance. | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. | Class II | Terminated | |
| Z-1506-2015 | M-4 Mechanism Set 16 mm and M-4 Mechanism Set 19 mm A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. | Class II | Terminated | |
| Z-1505-2015 | Specialty MiniScope Mech. Set Size 18, Specialty MiniScope Mech. Set Size 21, and Specialty MiniScope Mech. Set Size 24 A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance. | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. | Class II | Terminated | |
| Z-1504-2015 | TS Herbst Nuts with Backing (10/pk) and TS Herbst Nuts Universal (10/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance. | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. | Class II | Terminated | |
| Z-1503-2015 | MiniScope Hst ROC Crown 15 Patient Kit, and MiniScope Herbst Crown 15 Patient Kit A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance. | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. | Class II | Terminated | |
| Z-1502-2015 | Herbst Universal Nut which is used in a Herbst Appliance A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance. | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain