# Sterngold/Implamed

- Location (FDA's records): Attleboro, MA
- FDA decisions: 16 (1992–1999): 16 510(k) clearances
- Product codes: EJT (5), DZE (4), EJS (2), EMA (2), ELR (1), EBF (1), EBI (1)
- Predicates its devices cite: 24 (0 its own); citations of its devices by later devices: 5 (0 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
- Ivoclar North America, Inc.: 4 (https://510kreport.com/company/ivoclar-north-america)
- Dentsply Intl.: 3 (https://510kreport.com/company/dentsply-intl)
- Kerr Corporation (Danbury): 3 (https://510kreport.com/company/kerr-danbury)
- Bisco, Inc.: 2 (https://510kreport.com/company/bisco)
- Majestic Drug Co., Inc.: 1 (https://510kreport.com/company/majestic-drug)
- Jeneric/Pentron, Inc.: 1 (https://510kreport.com/company/jeneric-pentron)
- Sybron Dental Specialties, Inc.: 1 (https://510kreport.com/company/sybron-dental-specialties)
- Cosmedent, Inc.: 1 (https://510kreport.com/company/cosmedent)

## Firms that cite its devices most
- Sterngold: 1 (https://510kreport.com/company/sterngold)
- Straumann USA: 1 (https://510kreport.com/company/straumann-usa)
- Nobel Biocare AB: 1 (https://510kreport.com/company/nobel-biocare)
- Nobel Biocare Uas, Inc.: 1 (https://510kreport.com/company/nobel-biocare-uas)
- Intra-Lock International: 1 (https://510kreport.com/company/intra-lock-international)

## Its most-cited devices
- K981516: Sterngold Implamed Hex Screw Implant TPS Coated Sterngold Implamed Hex Screw Implant HA Coated , Refer to Table 1 in Sub (1998), cited by 4
- K913348: The Stern Era System (1992), cited by 1

## Recent decisions
- K984340: Sternomega Temporary Cement Automix NE, Model 220282/220281 (Jan 8, 1999)
- K984341: Sternvantage Varnish LC, Model 221001 (Jan 8, 1999)
- K983786: Sterngold Implamed Wide Platform Dental Implants and Related Prosthetics and Insttumentation (Nov 13, 1998)
- K982692: Sternomega Bonding Agent, Sternomega Composite LC, Sternomega Compomer LC (Oct 22, 1998)
- K982895: Sternomega Compomer Cement (Oct 9, 1998)
- K981516: Sterngold Implamed Hex Screw Implant TPS Coated Sterngold Implamed Hex Screw Implant HA Coated , Refer to Table 1 in Sub (May 11, 1998)
- K962326: Sterngold Bio-5 (1127210) (Jul 24, 1996)
- K962325: Quasar Yellow Crown and Bridge Alloy (1122015) (Jul 24, 1996)

Source page: https://510kreport.com/company/sterngold-implamed