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Renamel® Microhybrid

FDA UDI

Class II (US FDA UDI)

by DeltaMed GmbH

Identity

Trade Name
Renamel® Microhybrid FDA UDI
Generic Name
Dental composite resin FDA UDI
Device Name
Renamel® Microhybrid Body D2, Syringe 2g FDA UDI
Model / Reference
6161D2 FDA UDI
Description
Renamel® Microhybrid Body D2, Syringe 2g FDA UDI

Identifiers

Catalog Number
6161D2 FDA UDI
Primary DI / UDI-DI
EDEL6161D20 FDA UDI
510(k) Number
K222435 FDA UDI
FDA Product Code
EBF FDA UDI
GMDN Term
Dental composite resin FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3690 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI

Renamel® Microhybrid by DeltaMed GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K222435 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
DeltaMed GmbH

Sources (1)

  • FDA UDI 07edef1f-6a47-4788-8b6c-9c6b36740753 37 fields · synced May 31, 2026