# Coltene/Whaledent, Inc.

- Location (FDA's records): Mahwah, NJ
- FDA decisions: 41 (1991–2022): 41 510(k) clearances
- Names in FDA's records: Coltene/Whaledent, Inc. (21); Coltene/Whaledent AG (16); Coltene/Whaledent GmbH & Co. KG (2); Coltene/Whaledent (1); Coltène/Whaledent AG (1)
- Product codes: EBF (10), EMA (9), KLE (4), ELW (4), EBZ (3), ELR (3), FRG (2), ELC (2), KMH (1), KIF (1), MVL (1), EKZ (1)
- 510(k) review time since 2016: median 133 days, against 159 for FDA's reviews in the same codes and years (3 of 6 faster)
- Predicates its devices cite: 10 (3 its own); citations of its devices by later devices: 23 (3 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
- E.M.S Electro Medical Systems S.A: 1 (https://510kreport.com/company/ems-electro-medical-systems-s-a)
- Dentronix, Inc.: 1 (https://510kreport.com/company/dentronix)
- Coltene, Inc.: 1 (https://510kreport.com/company/coltene)
- Dentply International, Inc.: 1 (https://510kreport.com/company/dentply-international)
- Roeko USA, Inc.: 1 (https://510kreport.com/company/roeko-usa)
- GC America, Inc.: 1 (https://510kreport.com/company/gc-america)
- Ipco Corp.: 1 (https://510kreport.com/company/ipco)

## Firms that cite its devices most
- Sdi Limited: 4 (https://510kreport.com/company/sdi)
- Dent4you AG: 3 (https://510kreport.com/company/dent4you)
- Meta Biomed Co., Ltd.: 2 (https://510kreport.com/company/meta-biomed)
- Dmg Hamburg: 1 (https://510kreport.com/company/dmg-hamburg)
- Rizhao Huge Biomaterials Company, Ltd.: 1 (https://510kreport.com/company/rizhao-huge-biomaterials)
- Dxm Co., Ltd.: 1 (https://510kreport.com/company/dxm)
- Essential Dental Systems, Inc.: 1 (https://510kreport.com/company/essential-dental-systems)
- Edelweiss Dentistry Products GmbH: 1 (https://510kreport.com/company/edelweiss-dentistry-products)

## Its most-cited devices
- K053040: Paracem Universal DC (2005), cited by 4
- K040551: Coltolux Led Curing Light (2004), cited by 3
- K150218: Fill-Up! (2015), cited by 2
- K000311: Parapost Fiber White (2000), cited by 2
- K220097: PRESIDENT The Original (2022), cited by 1
- K052820: Parapost Paracore Automix 5ML (2006), cited by 1

## Recent decisions
- K220097: PRESIDENT The Original (Jan 13, 2022)
- K191385: Brilliant Componeer (Oct 29, 2019)
- K190597: BRILLIANT EverGlow Flow (Jun 21, 2019)
- K181500: BRILLIANT Crios (Aug 15, 2018)
- K160800: DuoCem (Nov 16, 2016)
- K152927: Brilliant Everglow (Apr 28, 2016)
- K152243: One Coat 7 Universal (Dec 9, 2015)
- K150218: Fill-Up! (Jun 23, 2015)

Source page: https://510kreport.com/company/coltene-whaledent