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Duran®+

FDA UDI

Class I (US FDA UDI)

by Scheu-Dental

Identity

Trade Name
DURAN®+ FDA UDI
Generic Name
Dental appliance fabrication material, thermoplastic FDA UDI
Device Name
DURAN®+ 1.0 x 114 x 499 mm strip FDA UDI
Model / Reference
3485.2 FDA UDI
Description
DURAN®+ 1.0 x 114 x 499 mm strip FDA UDI

Identifiers

Primary DI / UDI-DI
J01834852 FDA UDI
FDA Product Code
KMY FDA UDI
GMDN Term
Dental appliance fabrication material, thermoplastic FDA UDI

Classification

Device Class
Class I 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

Yes

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

Duran®+ by Scheu-Dental — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental appliance fabrication material, thermoplastic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Scheu-Dental

Sources (1)

  • FDA UDI 23da5070-939f-4ec4-8c04-59ede9527be7 34 fields · synced Jun 1, 2026