# Premier Dental Products Co.

- Location (FDA's records): Mchenry, IL
- FDA decisions: 44 (1977–2026): 44 510(k) clearances
- Names in FDA's records: Premier Dental Products Co. (41); Premier Dental Products Company (3)
- Product codes: KLE (4), EBF (4), EMA (4), EJR (2), MVL (2), EKH (1), EMS (1), EHY (1), EKN (1), ETF (1), EBI (1), GDG (1)
- 510(k) review time since 2016: median 1 days, against 63 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 16 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- 3M Deutschland GmbH: 1 (https://510kreport.com/company/3m-deutschland)
- Kerr Corporation: 1 (https://510kreport.com/company/kerr)
- Nobio, Ltd.: 1 (https://510kreport.com/company/nobio)

## Firms that cite its devices most
- Parkell, Inc.: 2 (https://510kreport.com/company/parkell)
- Sunstar Americas, Inc.: 1 (https://510kreport.com/company/sunstar-americas)
- Kerr Corporation: 1 (https://510kreport.com/company/kerr)
- Rounding Third, LLC: 1 (https://510kreport.com/company/rounding-third)
- Eastdent Co., Ltd.: 1 (https://510kreport.com/company/eastdent)
- Itena Clinical: 1 (https://510kreport.com/company/itena-clinical)
- Spident Co., Ltd.: 1 (https://510kreport.com/company/spident)
- Fusion Medical Technologies, Inc.: 1 (https://510kreport.com/company/fusion-medical-technologies)

## Its most-cited devices
- K033309: Premier Implant Cement, Model 3001450 (2004), cited by 3
- K132526: Knit-Pak+ (2013), cited by 2
- K062166: Enamel Pro (2006), cited by 2
- K083695: Traxodent (2009), cited by 2
- K891536: Enamel Microabrasion Compound (1989), cited by 1
- K771451: Scutabond (1977), cited by 1

## Recent decisions
- K260682: Bond-PR™ Universal Adhesive (Mar 3, 2026)
- K253513: MultiMatch Flow Chameleon AntiMicrobial Composite (Nov 7, 2025)
- K223632: Premier's MultiMatch Universal Chameleon Restorative Composite (Dec 6, 2022)
- K141839: Premier Etch (Nov 17, 2014)
- K132526: Knit-Pak+ (Nov 26, 2013)
- K131212: Premier Ceramic Primer (Aug 26, 2013)
- K083695: Traxodent (Apr 28, 2009)
- K062166: Enamel Pro (Nov 21, 2006)

Source page: https://510kreport.com/company/premier-dental-products