BrackFix

FDA UDI

Class II (US FDA UDI)

by VOCO GmbH

Identity

Trade Name: BrackFix FDA UDI
Generic Name: Orthodontic bracket adhesive FDA UDI
Model / Reference: 1209 FDA UDI

Identifiers

Primary DI / UDI-DI: E22112091 FDA UDI
510(k) Number: K183147 FDA UDI
FDA Product Code: DYH FDA UDI
GMDN Term: Orthodontic bracket adhesive FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3750 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Orthodontic bracket adhesive

BrackFix by VOCO GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic bracket adhesive.

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Resilience — ORTHO TECHNOLOGY, INC. · Class II
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Novocol GRANITEC PRIMER 9ML — Septodont · Class II
Light Bond — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class II
Light Cure Retainer — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class II
Rely a Bond — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class II

Cleared under the same submission

K183147 also covers:

BrackFix — VOCO GmbH
BrackFix — VOCO GmbH

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: VOCO GmbH

Sources (1)

FDA UDI 00623c45-e149-4d40-a88f-e5f5465ce66d 34 fields · synced Jun 1, 2026