# Pulpdent Corp.

- Location (FDA's records): Watertown, MA
- FDA decisions: 110 (1990–2021): 110 510(k) clearances
- Names in FDA's records: Pulpdent Corp. (78); Pulpdent Corporation (32)
- Product codes: EBF (29), EMA (14), KLE (11), EBC (10), LBH (10), DYH (9), KIF (6), EJK (4), EJR (3), EBG (2), EKJ (2), KJJ (1)
- Predicates its devices cite: 35 (18 its own); citations of its devices by later devices: 41 (18 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
- GC America, Inc.: 5 (https://510kreport.com/company/gc-america)
- Scientific Pharmaceuticals, Inc.: 2 (https://510kreport.com/company/scientific-pharmaceuticals)
- Inpharma A.S.: 2 (https://510kreport.com/company/inpharma)
- Kuraray Co.: 1 (https://510kreport.com/company/kuraray)
- 3M Company: 1 (https://510kreport.com/company/3m)
- 3M Espe Dental Products: 1 (https://510kreport.com/company/3m-espe-dental-products)
- Pulpdent Corp. of America: 1 (https://510kreport.com/company/pulpdent-of-america)
- Union Broach, Div. Moyco Industries, Inc.: 1 (https://510kreport.com/company/union-broach-div-moyco-industries)

## Firms that cite its devices most
- Meta Biomed Co., Ltd.: 3 (https://510kreport.com/company/meta-biomed)
- Kuraray Medical, Inc.: 2 (https://510kreport.com/company/kuraray-medical)
- 3M Company: 2 (https://510kreport.com/company/3m)
- CAO Group, Inc.: 2 (https://510kreport.com/company/cao-group)
- Apex Dental Materials, Inc.: 1 (https://510kreport.com/company/apex-dental-materials)
- GreenMark Biomedical, Inc.: 1 (https://510kreport.com/company/greenmark-biomedical)
- E Dental Products: 1 (https://510kreport.com/company/e-dental-products)
- 3M Espe Dental Products: 1 (https://510kreport.com/company/3m-espe-dental-products)

## Its most-cited devices
- K031915: Pulpdent Etch-Rite Royale (2003), cited by 4
- K052281: Embrace Wetbond Clear Sealant (2006), cited by 3
- K962743: Pulpdent Sodium Hypochlorite Solution (1996), cited by 3
- K020287: Dentition Integrating Material (2002), cited by 3
- K130223: Rmgi Fill (2013), cited by 3
- K963921: Pulpdent Seal-Rite Udma (1996), cited by 2

## Recent decisions
- K210045: Activa Presto Pack (Sep 22, 2021)
- K173020: OBA-MCP, Orthodontic Bracket Adhesive with MCP (Jan 17, 2018)
- K172169: Pulpdent (Activa) Pit and Fissure Sealant with MCP (Jan 5, 2018)
- K153249: Pulpdent Solo Flowable Composite with MCP (Apr 1, 2016)
- K130223: Rmgi Fill (Mar 29, 2013)
- K123265: Rmgi Low Viscosity (Dec 7, 2012)
- K120784: Tuff-Temp 2.0 (Jun 8, 2012)
- K120003: NUCAL (Apr 5, 2012)

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