← Back to catalogue

SmileGuard

FDA UDI

Class I (US FDA UDI)

by Envisiontec GmbH

Identity

Trade Name
SmileGuard FDA UDI
Generic Name
Removable dental occlusal splint, custom-made FDA UDI
Device Name
SmileGuard is a light-curing material for the additive manufacuring of flexible, individual dental bite splints. FDA UDI
Model / Reference
RES-01-3194 FDA UDI
Description
SmileGuard is a light-curing material for the additive manufacuring of flexible, individual dental bite splints. FDA UDI

Identifiers

Catalog Number
RES-01-3194 FDA UDI
Primary DI / UDI-DI
04260683220652 FDA UDI
510(k) Number
K220894 FDA UDI
FDA Product Code
KMY FDA UDI
MQC FDA UDI
GMDN Term
Removable dental occlusal splint, custom-made FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.5525 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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

Yes

FDA UDI

Category: Removable dental occlusal splint, custom-madeCustom-made mouthguard

SmileGuard by Envisiontec GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Custom-made mouthguard.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Envisiontec GmbH

Sources (1)

  • FDA UDI e7ebdb59-dbb3-4ec1-b87a-838717d94839 37 fields · synced May 31, 2026