# Heraeus Kulzer, Inc.

- Location (FDA's records): South Bend, IN
- FDA decisions: 170 (1988–2013): 170 510(k) clearances
- Names in FDA's records: Heraeus Kulzer, Inc. (145); Heraeus Kulzer, LLC (11); Heraeus Kulzer,GmbH (10); Heraeus Kulzer GmbH & Co. KG (4)
- Product codes: ELW (21), KLE (19), EBF (18), EBI (13), CGA (10), LOD (7), CFR (6), LCP (4), EJT (3), ELM (3), GKZ (3), EBG (2)
- Predicates its devices cite: 25 (16 its own); citations of its devices by later devices: 100 (16 its own)
- Recalls linked to its devices: 44 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Smith & Nephew Richards, Inc.: 5 (https://510kreport.com/company/smith-nephew-richards)
- Kulzer, Inc.: 2 (https://510kreport.com/company/kulzer)
- J.F. Jelenko & Co., Inc.: 1 (https://510kreport.com/company/jf-jelenko)
- 3M Company: 1 (https://510kreport.com/company/3m)

## Firms that cite its devices most
- Heraeus Medical GmbH: 8 (https://510kreport.com/company/heraeus-medical)
- Kuraray America, Inc.: 5 (https://510kreport.com/company/kuraray-america)
- Osartis GmbH: 4 (https://510kreport.com/company/osartis)
- G21, S.R.L.: 4 (https://510kreport.com/company/g21)
- Kulzer, Inc.: 4 (https://510kreport.com/company/kulzer)
- Biomet, Inc.: 3 (https://510kreport.com/company/biomet)
- Aap Biomaterials GmbH & Co. KG: 3 (https://510kreport.com/company/aap-biomaterials)
- ACON Laboratories, Inc.: 3 (https://510kreport.com/company/acon-laboratories)

## Its most-cited devices
- K031673: Refobacin -Palacos G (2004), cited by 9
- K030902: Palacos R (2003), cited by 9
- K951361: Dca 2000 System for Hemoglobin A1C (1995), cited by 5
- K050085: Osteopal V (2005), cited by 5
- K954115: Artglass & Kevloc (1995), cited by 5
- K000629: Flextime (2000), cited by 5

## Recent decisions
- K130647: Xantasil Dynamix Fast Set Cartridge -2 X 380ML; Xantasil Fast Set Cartridge -6 X 50ML (May 17, 2013)
- K123278: Ibond Self Etch Bottle Assortment, Ibond Self Etch Bottle Value Pack, Ibond Self Etch Single Dose Assortment, Ibond Self (Dec 7, 2012)
- K120914: Flexitime Fast & Scan Light Flow (Jul 25, 2012)
- K113574: Flexitime Monophase Pro Scan (Jul 13, 2012)
- K112501: Venus Pearl PLT Refill A1 (Dec 14, 2011)
- K111832: Paladon Ultra Powder (Pink), Paladon Ultra Liquid (Sep 29, 2011)
- K110037: Palaxpress Ultra Powder (Pink); Palaxpress Ultra Liquid (Apr 29, 2011)
- K102770: Flextime Fast & Scan Putty, Flextime Fast & Scan Light Flow, Flextime Fast & Scan Medium Flow (Dec 21, 2010)

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