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E-Guard Blue

FDA UDI

Class U (US FDA UDI)

by Envisiontec GmbH

Identity

Trade Name
E-Guard Blue FDA UDI
Generic Name
Removable dental occlusal splint, custom-made FDA UDI
Device Name
E-Guard Blue is a light-curing material for the additive manufacturing of individual dental bite splints FDA UDI
Model / Reference
RES-01-3121 FDA UDI
Description
E-Guard Blue is a light-curing material for the additive manufacturing of individual dental bite splints FDA UDI

Identifiers

Catalog Number
RES-01-3121 FDA UDI
Primary DI / UDI-DI
04260683220041 FDA UDI
510(k) Number
K201173 FDA UDI
FDA Product Code
MQC FDA UDI
GMDN Term
Removable dental occlusal splint, custom-made FDA UDI

Classification

Device Class
U 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

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

E-Guard Blue by Envisiontec GmbH — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Custom-made mouthguard.

Cleared under the same submission

K201173 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Envisiontec GmbH

Sources (1)

  • FDA UDI fc74e2eb-c916-4f19-b4b8-1a4687c28e67 37 fields · synced May 30, 2026