# Parkell, Inc.

- Location (FDA's records): Farmingdale, NY
- FDA decisions: 61 (1976–2025): 61 510(k) clearances
- Names in FDA's records: Parkell, Inc. (53); Parkell (8)
- Product codes: KLE (16), EMA (8), EBF (6), ELC (4), EBI (3), EBG (3), EAT (3), ELW (3), LQY (2), EBD (2), KOJ (1), EJK (1)
- 510(k) review time since 2016: median 137 days, against 143 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 18 (6 its own); citations of its devices by later devices: 19 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Premier Dental Products Co.: 2 (https://510kreport.com/company/premier-dental-products)
- 3M Espe AG: 1 (https://510kreport.com/company/3m-espe)
- Kuraray Noritake Dental, Inc.: 1 (https://510kreport.com/company/kuraray-noritake-dental)
- Produits Dentaires Pierre Rolland: 1 (https://510kreport.com/company/produits-dentaires-pierre-rolland)
- Septodont, Inc.: 1 (https://510kreport.com/company/septodont)
- Dmg USA, Inc.: 1 (https://510kreport.com/company/dmg-usa)
- Premier Dental Company Products: 1 (https://510kreport.com/company/premier-dental-company-products)
- Dentsply Interntional: 1 (https://510kreport.com/company/dentsply-interntional)

## Firms that cite its devices most
- Tokuyama America, Inc.: 3 (https://510kreport.com/company/tokuyama-america)
- Kuraray America, Inc.: 3 (https://510kreport.com/company/kuraray-america)
- Macan Engineering Co.: 1 (https://510kreport.com/company/macan-engineering)
- Tpc Advanced Technology, Inc.: 1 (https://510kreport.com/company/tpc-advanced-technology)
- Inter-Med, Inc.: 1 (https://510kreport.com/company/inter-med)
- Sterngold/Implamed: 1 (https://510kreport.com/company/sterngold-implamed)
- Dmg USA, Inc.: 1 (https://510kreport.com/company/dmg-usa)
- Arthrocare Corp.: 1 (https://510kreport.com/company/arthrocare)

## Its most-cited devices
- K960464: C & B Metabond (Modification) (1996), cited by 7
- K950239: Sensimatic 500SE (1995), cited by 2
- K942017: V-Primer (1994), cited by 1
- K950256: TURBO 25/30 (1995), cited by 1
- K243254: Parkell Pit and Fissure Sealant (2025), cited by 1
- K010475: D/C Core Material (2001), cited by 1

## Recent decisions
- K243254: Parkell Pit and Fissure Sealant (Aug 8, 2025)
- K210259: Parkell Self-Adhesive Cement (Jan 20, 2022)
- K191103: Parkell Desensitizer Gel (Nov 22, 2019)
- K190930: SmarTemp X1 (Sep 5, 2019)
- K182296: HyperFil-LV (Dec 14, 2018)
- K172176: Parkell Universal Adhesive (Nov 21, 2017)
- K151518: Brush&Bond Plus (Sep 18, 2015)
- K142848: Eazy Primer (Feb 24, 2015)

Source page: https://510kreport.com/company/parkell