# Ivoclar North America, Inc.

- Location (FDA's records): Amherst, NY
- FDA decisions: 131 (1989–2001): 131 510(k) clearances
- Product codes: EJT (29), EBF (28), EJS (12), EIH (10), EMA (9), KLE (5), EJH (4), EJJ (4), EBI (4), EBG (3), EBZ (3), ELL (2)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 54 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Dmg USA, Inc.: 6 (https://510kreport.com/company/dmg-usa)
- Kuraray America, Inc.: 5 (https://510kreport.com/company/kuraray-america)
- Sterngold/Implamed: 4 (https://510kreport.com/company/sterngold-implamed)
- Wieland Dental + Technik GmbH & Co. KG: 3 (https://510kreport.com/company/wieland-dental-technik)
- Ivoclar Vivadent, Inc.: 3 (https://510kreport.com/company/ivoclar-vivadent)
- Sterngold: 2 (https://510kreport.com/company/sterngold)
- Vertex-Dental B.V.: 2 (https://510kreport.com/company/vertex-dental)
- 3M Company: 2 (https://510kreport.com/company/3m)

## Its most-cited devices
- K993783: Tetric Flow (1999), cited by 7
- K913655: Probase Hot and Probase Cold (1991), cited by 4
- K962878: Targis System (1996), cited by 4
- K931309: Variolink (1993), cited by 4
- K971372: Variolink II (1997), cited by 4
- K982616: Ips Empress 2 (1998), cited by 4

## Recent decisions
- K012174: Eris Layering Materials (Aug 27, 2001)
- K011491: Helioseal Clear Chroma (Aug 16, 2001)
- K011492: IN Ten-S (Jul 5, 2001)
- K011490: Modification to Excite (Jun 27, 2001)
- K011023: D.SIGN 96 (May 2, 2001)
- K011022: Biouniversal PDF (May 2, 2001)
- K010381: D.SIGN 30 (Mar 6, 2001)
- K010250: Tetric Ceram HB (Feb 28, 2001)

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