Nusmile, Ltd
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000021910 FEI 3006444232
- Devices
- 1,907
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
What Nusmile, Ltd makes
NuSmile, Ltd. manufactures preformed dental crowns, including temporary and replacement types for both pediatric and adult patients, with stainless steel and other materials. The company also produces single-use rotary and reciprocating endodontic files, hygroscopic dental cements, orthodontic space maintainers, endodontic paper points, natural gutta-percha, and dental material injection cannulas. Manual non-rotary dental instrument handles are part of its portfolio, alongside silver diamine fluoride solutions for dental caries management.
NuSmile’s devices are classified under FDA’s Class I and Class II categories, with some listed as unclassified (U). The products are registered in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.
Catalogue
Search and filter all 1,907 devicesShowing 1-50 of 1,907
Company details
- EUDAMED SRN
- US-MF-000021910
- FDA FEI number
- 3006444232
- EUDAMED status
- Active
- EUDAMED registered name
- NuSmile, Ltd.
- Registered address
- 3315, West 12th Street, 77008, Houston, United States
- Website
- nusmile.com
- plara@nusmile.com
- Phone
- 713-861-0033
- PRRC contact
- Priscilla Lara
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 6 Nov 2030
SGS Belgium NV 1639 1 certificate
- US25/00000460 Active
Quality management system EU MDR
- Issued
- 31 Jul 2026
- Expires
- 6 Nov 2030
- Reason
- Other
Frequently asked questions
How many devices does NUSMILE, LTD have in the registry?
The registry currently lists 1907 devices for NUSMILE, LTD. Devices recorded under merged duplicate company entries are counted once.
Which registries list NUSMILE, LTD's devices?
Among its 50 most recently registered devices, NUSMILE, LTD has devices listed in EUDAMED (1 device) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do NUSMILE, LTD's devices fall under?
Among its 50 most recently registered devices, the classes recorded for NUSMILE, LTD's devices are Class I and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for NUSMILE, LTD?
EUDAMED lists 1 certificate for NUSMILE, LTD (quality management system) under MDR. The most recent was issued on 31 Jul 2026.
What are the newest devices from NUSMILE, LTD in the registry?
The most recently registered devices listed for NUSMILE, LTD include NuSmile NuCem NCRPK, NuSmile NuCem NCRSK, NuSmile NuCem NUCEMSU and NuSmile NuCem NCRSKI.