Prime Dental Manufacturing, Inc.
Chicago, IL, US
PRIME DENTAL MANUFACTURING, INC. appears in FDA device records in Chicago, IL. FDA records list 9 510(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 9 510(k) clearances for Prime Dental Manufacturing, Inc. between 2000 and 2012. The busiest year on record is 2001, with 3. The most recent is 2012, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 2 |
| 2001 | 3 |
| 2002 | 3 |
| 2012 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K112574 | PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT | EMA | Substantially Equivalent | |
| K022675 | PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL | EBF | Substantially Equivalent | |
| K021524 | LIGHT CURE DENTAL DAM | EIE | Substantially Equivalent | |
| K013970 | PRIME-DENT HEMA DESENSITIZER | EBF | Substantially Equivalent | |
| K012794 | PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT | EBF | Substantially Equivalent | |
| K012761 | PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT | EBC | Substantially Equivalent | |
| K012673 | PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM | DYH | Substantially Equivalent | |
| K001108 | PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL | EBF | Substantially Equivalent | |
| K994224 | PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL | EBF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1424442 | 3002811563 | PRIME DENTAL MANUFACTURING, INC. | 4555 W Addison St, CHICAGO, IL 60641 US | 2026 | and 7 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NDPAccessories, Implant, Dental, Endosseous
- DYHAdhesive, Bracket And Tooth Conditioner, Resin
- KLEAgent, Tooth Bonding, Resin
- KXRApplicator, Resin
- EMACement, Dental
- ELZCrown, Preformed
- EIEDam, Rubber
- PMEExternal Cleaning Solution
- ECPInstrument, Ligature Tucking, Orthodontic
- EBHMaterial, Impression Tray, Resin
- EBFMaterial, Tooth Shade, Resin
- EKQPreparer, Root Canal Endodontic
- BRWProtector, Dental
- EBCSealant, Pit And Fissure, And Conditioner
- EAPUnit, X-Ray, Intraoral
- EGDWax, Dental, Intraoral
- EMBZinc Oxide Eugenol
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