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edelweiss CAD/CAM T-BLOCK Universal Enamel (10 +2 more)

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref 21100

by edelweiss dentistry products gmbh

Identity

Trade Name
edelweiss CAD/CAM T-BLOCK Universal Enamel (10/12/16mm) EUDAMED
edelweiss CAD/CAM T-BLOCK Universal Enamel (10/12/16) FDA UDI
Generic Name
Dental appliance fabrication material, combination-material FDA UDI
Device Name
CAD/CAM BLOCK EUDAMED
5pcs edelweiss CAD/CAM T-BLOCK Universal Enamel (10/12/16) FDA UDI
Model / Reference
21100 EUDAMEDFDA UDI
Description
5pcs edelweiss CAD/CAM T-BLOCK Universal Enamel (10/12/16) FDA UDI

Identifiers

Primary DI / UDI-DI
09120046322537 EUDAMEDFDA UDI
Basic UDI-DI
912004632BlockFA EUDAMED
510(k) Number
K241131 FDA UDI
FDA Product Code
EBF FDA UDI
EMDN Code
Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
GMDN Term
Dental appliance fabrication material, combination-material FDA UDI
Models / Variants
10 EUDAMEDFDA UDIFDA 510(k)
12 EUDAMEDFDA UDIFDA 510(k)
16mm EUDAMEDFDA UDIFDA 510(k)

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
872.3690 FDA UDI
Market of Registration
Austria EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

edelweiss CAD/CAM T-BLOCK Universal Enamel (10 +2 more) by Edelweiss Dentistry Products Gmbh — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA…

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
edelweiss dentistry products gmbh
EUDAMED SRN
AT-MF-000005413

Sources (3)

  • EUDAMED b3544f53-b806-41a0-bc34-e8d9865a2a3b 61 fields · synced Jun 19, 2026
  • FDA UDI 569b2648-7735-4754-a46e-6851abcdfc0d 34 fields · synced May 30, 2026
  • FDA 510(k) K241131 1 fields · synced Jun 9, 2026