← Back to catalogue

Erkodur freeze

FDA UDI

Class U (US FDA UDI)

by Erkodent Erich Kopp GmbH

Identity

Trade Name
Erkodur freeze FDA UDI
Generic Name
Dental appliance fabrication material, thermoplastic FDA UDI
Device Name
Erkodur freeze, 2.00 mm, Ø 120 mm, turquoise. Thermoforming sheet material for the fabrication of orthodontic and dental appliances. FDA UDI
Model / Reference
529120 FDA UDI
Description
Erkodur freeze, 2.00 mm, Ø 120 mm, turquoise. Thermoforming sheet material for the fabrication of orthodontic and dental appliances. FDA UDI

Identifiers

Primary DI / UDI-DI
ERKO5291201 FDA UDI
510(k) Number
K200125 FDA UDI
FDA Product Code
MQC FDA UDI
KMY FDA UDI
GMDN Term
Dental appliance fabrication material, thermoplastic FDA UDI

Classification

Device Class
U FDA UDI
Regulation Number
872.5525 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

No

FDA UDI

Category: Dental appliance fabrication material, thermoplastic

Erkodur freeze by Erkodent Erich Kopp GmbH — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental appliance fabrication material, thermoplastic.

Cleared under the same submission

K200125 also covers:

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
Erkodent Erich Kopp GmbH

Sources (1)

  • FDA UDI bb62f93b-149b-4d42-9798-cae52937638d 35 fields · synced Jun 8, 2026