# GC America, Inc.

- Location (FDA's records): Alsip, IL
- FDA decisions: 129 (1993–2026): 129 510(k) clearances
- Product codes: EMA (30), EBF (24), ELW (15), EBI (12), KLE (11), EIH (8), EBG (6), DYH (6), NHA (3), EJR (2), DZE (2), EBZ (2)
- 510(k) review time since 2016: median 204 days, against 159 for FDA's reviews in the same codes and years (4 of 25 faster)
- Predicates its devices cite: 99 (49 its own); citations of its devices by later devices: 110 (49 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 Vivadent, Inc.: 5 (https://510kreport.com/company/ivoclar-vivadent)
- Atlantis Components, Inc.: 5 (https://510kreport.com/company/atlantis-components)
- Astra Tech, Inc.: 4 (https://510kreport.com/company/astra-tech)
- Jensen Industries, Inc.: 3 (https://510kreport.com/company/jensen-industries)
- 3M Espe Dental Products: 2 (https://510kreport.com/company/3m-espe-dental-products)
- 3M Espe AG: 2 (https://510kreport.com/company/3m-espe)
- Sybron Dental Specialties, Inc.: 2 (https://510kreport.com/company/sybron-dental-specialties)
- Innova Corp.: 2 (https://510kreport.com/company/innova)

## Firms that cite its devices most
- Silmet, Ltd.: 8 (https://510kreport.com/company/silmet)
- Pulpdent Corp.: 5 (https://510kreport.com/company/pulpdent)
- Tokuyama Dental Corporation: 4 (https://510kreport.com/company/tokuyama-dental)
- Voco GmbH: 3 (https://510kreport.com/company/voco)
- 3M Espe Dental Products: 2 (https://510kreport.com/company/3m-espe-dental-products)
- Genoss Co., Ltd.: 2 (https://510kreport.com/company/genoss)
- Shandong Huge Dental Material Corporation: 2 (https://510kreport.com/company/shandong-huge-dental-material)
- 3M Company: 2 (https://510kreport.com/company/3m)

## Its most-cited devices
- K091388: GCUC-505 (2009), cited by 6
- K133824: Cerasmart (2014), cited by 5
- K082434: GDLS-200 (2008), cited by 5
- K123631: MFP-051 (2013), cited by 5
- K946100: Fuji Duet (1995), cited by 4
- K133836: Optiglaze Color (2014), cited by 4

## Recent decisions
- K262202: Cerasmart Forte (Sep 10, 2026)
- K253317: Cytrans™ Elashield (Jul 6, 2026)
- K261246: SRGC-06 (Jun 18, 2026)
- K254109: G-Cem Universal (May 18, 2026)
- K251124: G-Bond Universal (Oct 2, 2025)
- K250953: Equia LC One (Sep 19, 2025)
- K251946: G aenial Universal Injectable II (Aug 29, 2025)
- K200798: G-Cem One (Nov 24, 2020)

Source page: https://510kreport.com/company/gc-america