Smilers

FDA UDI

Class II (US FDA UDI)

by Biotech Dental Smilers

Identity

Trade Name: Smilers FDA UDI
Generic Name: Orthodontic retainer FDA UDI
Model / Reference: Passive Appliance FDA UDI

Identifiers

Catalog Number: GOUTPA FDA UDI
Primary DI / UDI-DI: 03770020010040 FDA UDI
510(k) Number: K212961 FDA UDI
FDA Product Code: NXC FDA UDI
GMDN Term: Orthodontic retainer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.5470 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Orthodontic retainer

Smilers by Biotech Dental Smilers — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K212961 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Biotech Dental Smilers

Sources (1)

FDA UDI fa7ec04b-57d5-4d12-869e-c8743bef17c0 34 fields · synced May 30, 2026