Sterngold Dental LLC
Attleboro, MA, US
Sterngold Dental LLC appears in FDA device records in Attleboro, MA. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 12 510(k) clearances for Sterngold Dental LLC between 2012 and 2017. The busiest year on record is 2015, with 4. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2013 | 2 |
| 2014 | 3 |
| 2015 | 4 |
| 2016 | 1 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K171728 | MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm | DZE | Substantially Equivalent | |
| K153173 | MOR Implant System | DZE | Substantially Equivalent | |
| K151928 | PUR Dental Implant System | DZE | Substantially Equivalent | |
| K150968 | TRU Dental Implant System | DZE | Substantially Equivalent | |
| K150250 | SternSnap Angled Attachment | NHA | Substantially Equivalent | |
| K142667 | Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm, Stern AC 4.0x10mm | DZE | Substantially Equivalent | |
| K142407 | Straight Stud Attachment | NHA | Substantially Equivalent | |
| K133791 | ORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], ORA 4.0MM [S] | NHA | Substantially Equivalent | |
| K132814 | SFI-BAR IMPLANT ABUTMENTS | NHA | Substantially Equivalent | |
| K130183 | SFI BAR ABUTMENTS | NHA | Substantially Equivalent | |
| K130408 | ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT | NHA | Substantially Equivalent | |
| K111798 | STERNIC IMPLANT 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN, 1.8MM, 12.0MM / 4.1MM RN, 1.8MM, 14.0MM ... | DZE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2921595 | 2921595 | Sterngold Dental LLC | 23 Frank Mossberg Drive, Attleboro, MA 02703 US | 2026 | and 5 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NHAAbutment, Implant, Dental, Endosseous
- NDPAccessories, Implant, Dental, Endosseous
- EJTAlloy, Gold-Based Noble Metal
- EJSAlloy, Other Noble Metal
- EGGAttachment, Precision, All
- EMACement, Dental
- EBGCrown And Bridge, Temporary, Resin
- DZEImplant, Endosseous, Root-Form
- EIYInstrument, Filling, Plastic, Dental
- ELWMaterial, Impression
- EBHMaterial, Impression Tray, Resin
- EBFMaterial, Tooth Shade, Resin
- ELRPost, Root Canal
- EBIResin, Denture, Relining, Repairing, Rebasing
- EBCSealant, Pit And Fissure, And Conditioner
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain