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Flexcera Base Ultra+ Pink

FDA UDIEUDAMED

Class II (US FDA UDI)

by Envisiontec GmbH

Identity

Trade Name
Flexcera Base Ultra+ Pink FDA UDI
Generic Name
Denture base resin kit FDA UDI
Device Name
Flexcera Base Ultra+ is a light-curing material for the additive manufacturing of individual and removable full and partial denture bases FDA UDI
Model / Reference
RES-01-3500 FDA UDI
Description
Flexcera Base Ultra+ is a light-curing material for the additive manufacturing of individual and removable full and partial denture bases FDA UDI

Identifiers

Catalog Number
RES-01-3500 FDA UDI
Primary DI / UDI-DI
04260683220911 FDA UDI
510(k) Number
K210977 FDA UDI
FDA Product Code
EBI FDA UDI
GMDN Term
Denture base resin kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3760 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: Denture base resin kit

Flexcera Base Ultra+ Pink by Envisiontec GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Denture base resin kit.

Cleared under the same submission

K210977 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Envisiontec GmbH

Sources (2)

  • FDA UDI 3d454e83-9768-4952-a078-26ef5909ab20 37 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced Jun 5, 2026