Primer

FDA UDI

Class II (US FDA UDI)

by Five Star Orthodontic Laboratory & Supply, Inc.

Identity

Trade Name: PRIMER FDA UDI
Generic Name: Orthodontic bracket adhesive FDA UDI
Model / Reference: 1330255 FDA UDI

Identifiers

Primary DI / UDI-DI: D82813302550 FDA UDI
510(k) Number: K071688 FDA UDI
FDA Product Code: KLE FDA UDI
GMDN Term: Orthodontic bracket adhesive FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3200 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

FDA UDI

Manufacturing Date

FDA UDI

Category: Orthodontic bracket adhesive

Primer by Five Star Orthodontic Laboratory & Supply, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Orthodontic bracket adhesive.

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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

K071688 also covers:

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: Five Star Orthodontic Laboratory & Supply, Inc.

Sources (1)

FDA UDI 69b41248-ef37-453b-9cf8-e3d83c1f17ac 33 fields · synced Jun 7, 2026