Smilers

FDA UDI

Class II (US FDA UDI)

by Biotech Dental Smilers

Identity

Trade Name: Smilers FDA UDI
Generic Name: Orthodontic progressive aligner FDA UDI
Model / Reference: Reproduction Aligner FDA UDI

Identifiers

Catalog Number: ALIGN_REPRO FDA UDI
Primary DI / UDI-DI: 03770020010088 FDA UDI
510(k) Number: K212961 FDA UDI
FDA Product Code: NXC FDA UDI
GMDN Term: Orthodontic progressive aligner 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

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 progressive aligner

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

Similar devices

Also classified as Orthodontic progressive aligner.

Risas Reveal® — Ortho Organizers, Inc. · Class II
Reveal® Aligners — Ortho Organizers, Inc. · Class II
SLX® Clear Aligners — Ortho Organizers, Inc. · Class II
Reveal® Clear Aligners — Ortho Organizers, Inc. · Class II
3M™ Clarity™ — 3M UNITEK CORPORATION · Class II
Risas Reveal Aligners — Ortho Organizers, Inc. · Class II
Reveal® Clear Aligners — Ortho Organizers, Inc. · Class II
Reveal® Clear Aligners — Ortho Organizers, Inc. · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Biotech Dental Smilers

Sources (1)

FDA UDI 16166c12-b0f3-4b26-82fb-01fa9e8373d6 34 fields · synced Jun 8, 2026