# 3M Espe Dental Products

- Location (FDA's records): St. Paul, MN
- FDA decisions: 12 (2006–2023): 12 510(k) clearances
- Product codes: EMA (4), EBF (4), LBH (2), KLE (1), EJK (1)
- 510(k) review time since 2016: median 16 days, against 159 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 27 (3 its own); citations of its devices by later devices: 32 (3 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- 3M Company: 9 (https://510kreport.com/company/3m)
- 3M Espe AG Dental Products: 3 (https://510kreport.com/company/3m-espe-ag-dental-products)
- GC America, Inc.: 2 (https://510kreport.com/company/gc-america)
- Kuraray Medical, Inc.: 2 (https://510kreport.com/company/kuraray-medical)
- Dentsply International, Inc.: 1 (https://510kreport.com/company/dentsply-international)
- Sybron Dental Specialties, Inc.: 1 (https://510kreport.com/company/sybron-dental-specialties)
- Pulpdent Corp.: 1 (https://510kreport.com/company/pulpdent)
- Kuraray Co.: 1 (https://510kreport.com/company/kuraray)

## Firms that cite its devices most
- 3M Company: 4 (https://510kreport.com/company/3m)
- Mediclus Co., Ltd.: 3 (https://510kreport.com/company/mediclus)
- GC America, Inc.: 2 (https://510kreport.com/company/gc-america)
- Bisco, Inc.: 2 (https://510kreport.com/company/bisco)
- Kerr Corporation: 2 (https://510kreport.com/company/kerr)
- Spident Co., Ltd.: 2 (https://510kreport.com/company/spident)
- Dental Laboratory Milling Supplies, LLC (Dlms): 1 (https://510kreport.com/company/dental-laboratory-milling-supplies-dlms)
- Juno Dentistry LP: 1 (https://510kreport.com/company/juno-dentistry)

## Its most-cited devices
- K092141: Vanish Varnish, 5% Sodium Fluoride White Varnish (2010), cited by 7
- K120453: Filtek Bulk Fill Flowable Restorative (2012), cited by 6
- K111185: Relyx Luting Plus Automix (2011), cited by 5
- K110131: Lava Ultimate Cad/Cam Restorative for Cerec / E4D, Lava Ultimate Implant Crown Restorative (2011), cited by 5
- K183476: 3M Filtek Universal Restorative (2019), cited by 3
- K141081: Filtek Bulk Fill Posterior Restroative (2014), cited by 3

## Recent decisions
- K231338: 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment (May 10, 2023)
- K230270: 3M™ VitCal Liner/Base (Feb 6, 2023)
- K191122: 3M RelyX Pediatric Resin Modified Glass Ionomer Cement (May 29, 2019)
- K183476: 3M Filtek Universal Restorative (Jan 2, 2019)
- K141081: Filtek Bulk Fill Posterior Restroative (May 8, 2014)
- K120453: Filtek Bulk Fill Flowable Restorative (Mar 19, 2012)
- K111185: Relyx Luting Plus Automix (May 5, 2011)
- K110131: Lava Ultimate Cad/Cam Restorative for Cerec / E4D, Lava Ultimate Implant Crown Restorative (Jan 21, 2011)

Source page: https://510kreport.com/company/3m-espe-dental-products