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Erkoflex

FDA UDI

Class U (US FDA UDI)

by Erkodent Erich Kopp GmbH

Identity

Trade Name
Erkoflex FDA UDI
Generic Name
Dental appliance fabrication material, thermoplastic FDA UDI
Device Name
Erkoflex, 2.00 mm, Ø 120 mm, bright red. Thermoforming sheet material for the fabrication of orthodontic and dental appliances. FDA UDI
Model / Reference
581221 FDA UDI
Description
Erkoflex, 2.00 mm, Ø 120 mm, bright red. Thermoforming sheet material for the fabrication of orthodontic and dental appliances. FDA UDI

Identifiers

Primary DI / UDI-DI
ERKO5812211 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

Erkoflex 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

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Manufacturer

Manufacturer
Erkodent Erich Kopp GmbH

Sources (1)

  • FDA UDI 83f46354-71ac-4758-ba17-6357bd9571c6 35 fields · synced Jun 8, 2026