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NuSmile NuNamel Varnish

FDA UDI

Class II (US FDA UDI)

by Nusmile, Ltd

Identity

Trade Name
NuSmile NuNamel Varnish FDA UDI
Generic Name
Dental coating, tooth-desensitizing, professional FDA UDI
Device Name
NuSmile NuNamel Varnish Unit Dose 200 pk Kit - Bubblegum FDA UDI
Model / Reference
NNVB200 FDA UDI
Description
NuSmile NuNamel Varnish Unit Dose 200 pk Kit - Bubblegum FDA UDI

Identifiers

Primary DI / UDI-DI
00810118103711 FDA UDI
510(k) Number
K132109 FDA UDI
FDA Product Code
LBH FDA UDI
GMDN Term
Dental coating, tooth-desensitizing, professional FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3260 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental coating, tooth-desensitizing, professional

NuSmile NuNamel Varnish by Nusmile, Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental coating, tooth-desensitizing, professional.

Cleared under the same submission

K132109 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nusmile, Ltd

Sources (1)

  • FDA UDI 8ac09804-fe54-404f-b30a-4097505afd21 34 fields · synced May 30, 2026