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BioBleach® soft

FDA UDI

Class I (US FDA UDI)

by Dreve Dentamid GmbH

Identity

Trade Name
BioBleach® soft FDA UDI
Generic Name
Dental appliance fabrication material, thermoplastic FDA UDI
Device Name
No. FDA UDI
Model / Reference
D4300S FDA UDI
Description
No. FDA UDI

Identifiers

Catalog Number
D4300S FDA UDI
Primary DI / UDI-DI
E239D4300S1 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

No

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

BioBleach® soft by Dreve Dentamid GmbH — 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
Dreve Dentamid GmbH

Sources (1)

  • FDA UDI a91bf448-e61b-44df-8966-6a7ed6b8d83e 36 fields · synced May 30, 2026