# Kulzer, Inc.

- Location (FDA's records): Chicago, IL
- FDA decisions: 38 (1981–2026): 38 510(k) clearances
- Names in FDA's records: Kulzer, Inc. (31); Kulzer, LLC (7)
- Product codes: EBF (19), EBZ (3), EBG (3), EBI (3), EMA (3), EBH (2), EJJ (1), ELW (1), MVL (1), KLE (1), EGD (1)
- 510(k) review time since 2016: median 110 days, against 97 for FDA's reviews in the same codes and years (3 of 6 faster)
- Predicates its devices cite: 14 (1 its own); citations of its devices by later devices: 17 (1 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
- Heraeus Kulzer, Inc.: 4 (https://510kreport.com/company/heraeus-kulzer)
- Vita Zahnfabrik H.Rauter GmbH & Co.: 3 (https://510kreport.com/company/vita-zahnfabrik-h-rauter)
- Dentca, Inc.: 2 (https://510kreport.com/company/dentca)
- GC America, Inc.: 1 (https://510kreport.com/company/gc-america)
- Vident: 1 (https://510kreport.com/company/vident)
- Produits Dentaires Pierre Rolland: 1 (https://510kreport.com/company/produits-dentaires-pierre-rolland)
- Centrix, Inc.: 1 (https://510kreport.com/company/centrix)

## Firms that cite its devices most
- Espe Dental AG: 3 (https://510kreport.com/company/espe-dental)
- Heraeus Kulzer, Inc.: 2 (https://510kreport.com/company/heraeus-kulzer)
- Sun Medical, Inc.: 1 (https://510kreport.com/company/sun-medical)
- Enamelite, LLC: 1 (https://510kreport.com/company/enamelite)
- Vita Zahnfabrik H.Rauter GmbH & Co.: 1 (https://510kreport.com/company/vita-zahnfabrik-h-rauter)
- Kettenbach GmbH & Co. KG: 1 (https://510kreport.com/company/kettenbach)
- Dental Solutions, Inc.: 1 (https://510kreport.com/company/dental-solutions)
- Newave Medical, Inc.: 1 (https://510kreport.com/company/newave-medical)

## Its most-cited devices
- K892452: Palaseal (R) (1989), cited by 4
- K902115: Palapress (R) Vario Resin (1990), cited by 4
- K901789: Paladon (R) 65 (1990), cited by 3
- K220605: Venus Bulk Flow ONE (2022), cited by 2
- K892456: Kulzer Translux EC (1989), cited by 1
- K240660: Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active (2024), cited by 1

## Recent decisions
- K260783: Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One (Mar 11, 2026)
- K254063: iCEM Universal Plus (Dec 19, 2025)
- K243910: Retraxil (Sep 24, 2025)
- K240660: Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active (Sep 17, 2024)
- K233868: dima Print Teeth & Temp (May 23, 2024)
- K230644: Signum opaque F (Sep 7, 2023)
- K220605: Venus Bulk Flow ONE (Apr 21, 2022)
- K905058: Palavit L (Jun 6, 1991)

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