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Crown-Lok

FDA UDI

Class II (US FDA UDI)

by Reliance Orthodontic Products, Inc.

Identity

Trade Name
Crown-Lok FDA UDI
Generic Name
Dental prosthesis veneer resin FDA UDI
Device Name
Crown Lok™ is intended for use as a cement for metal crowns and orthodontic bands. Crown Lok Kit contains (4) 6gm Screw Paste A Syringes and (4) 6gm Screw Paste B Syringes and a 9gm etch. Crown Lok is a self-curing two minute working time fluoride releasing cement. FDA UDI
Model / Reference
CL FDA UDI
Description
Crown Lok™ is intended for use as a cement for metal crowns and orthodontic bands. Crown Lok Kit contains (4) 6gm Screw Paste A Syringes and (4) 6gm Screw Paste B Syringes and a 9gm etch. Crown Lok is a self-curing two minute working time fluoride releasing cement. FDA UDI

Identifiers

Catalog Number
CL FDA UDI
Primary DI / UDI-DI
D798CL0 FDA UDI
FDA Product Code
EBF FDA UDI
KLE FDA UDI
GMDN Term
Dental prosthesis veneer resin FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3690 FDA UDI
872.3200 FDA UDI
Commercial Distribution
Not 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

Yes

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

No

FDA UDI

Crown-Lok by Reliance Orthodontic Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Reliance Orthodontic Products, Inc.

Sources (1)

  • FDA UDI 461f29cf-d41a-46c4-9b0e-07c8e634adae 37 fields · synced May 30, 2026