# Dmg USA, Inc.

- Location (FDA's records): Ayer, MA
- FDA decisions: 28 (2000–2018): 28 510(k) clearances
- Product codes: EBF (7), EBG (5), EMA (4), ELW (3), KLE (2), EBC (2), EBD (1), ELY (1), MVL (1), EIH (1), EMB (1)
- Predicates its devices cite: 66 (8 its own); citations of its devices by later devices: 27 (8 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 North America, Inc.: 6 (https://510kreport.com/company/ivoclar-north-america)
- 3M Company: 6 (https://510kreport.com/company/3m)
- Bisco, Inc.: 5 (https://510kreport.com/company/bisco)
- Foremost Dental Mfg., Inc.: 4 (https://510kreport.com/company/foremost-dental-mfg)
- Voco GmbH: 4 (https://510kreport.com/company/voco)
- Dmg Chemisch Pharmazeutische Fabrik GmbH: 2 (https://510kreport.com/company/dmg-chemisch-pharmazeutische-fabrik)
- Kerr Dental Materials Center: 2 (https://510kreport.com/company/kerr-dental-materials-center)
- Sybron Dental Specialties, Inc.: 2 (https://510kreport.com/company/sybron-dental-specialties)

## Firms that cite its devices most
- Zest Anchors, Inc.: 2 (https://510kreport.com/company/zest-anchors)
- Kettenbach GmbH & Co. KG: 2 (https://510kreport.com/company/kettenbach)
- GC America, Inc.: 2 (https://510kreport.com/company/gc-america)
- Itena Clinical: 2 (https://510kreport.com/company/itena-clinical)
- Deltamed GmbH: 1 (https://510kreport.com/company/deltamed)
- Bisco, Inc.: 1 (https://510kreport.com/company/bisco)
- Wieland Dental + Technik GmbH & Co. KG: 1 (https://510kreport.com/company/wieland-dental-technik)
- Mediclus Co., Ltd.: 1 (https://510kreport.com/company/mediclus)

## Its most-cited devices
- K101710: Luxatemp Ultra /Star (2010), cited by 6
- K012307: Luxacore/Luxacore Dual (2001), cited by 6
- K012316: Permacem / Permacem Dual (2001), cited by 3
- K013674: Luxatemp/Luxatemp Solar/Instatemp (2002), cited by 2
- K011211: Flowable Composite/ Ecuflow/ Luxaflow (2001), cited by 2
- K002086: Primaflow (2000), cited by 1

## Recent decisions
- K171772: Ecosite Bulk Fill (Jan 31, 2018)
- K160443: TempoCem Clear (Sep 30, 2016)
- K130580: Retraction Paste (Feb 25, 2014)
- K110759: Tempocem (Jun 10, 2011)
- K102603: SA Flowable Adhesive (Nov 17, 2010)
- K101710: Luxatemp Ultra /Star (Sep 28, 2010)
- K100062: Infiltration Kit (Mar 26, 2010)
- K093338: Self Adhesive Composite Luting Cement (Feb 12, 2010)

Source page: https://510kreport.com/company/dmg-usa