Pit And Fissure Sealant Op

FDA UDI

Class II (US FDA UDI)

by Five Star Orthodontic Laboratory & Supply, Inc.

Identity

Trade Name: PIT AND FISSURE SEALANT OP FDA UDI
Generic Name: Dental pit/fissure sealant FDA UDI
Model / Reference: 1330229 FDA UDI

Identifiers

Primary DI / UDI-DI: D8281330229 FDA UDI
510(k) Number: K093059 FDA UDI
FDA Product Code: EBC FDA UDI
GMDN Term: Dental pit/fissure sealant FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3765 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: Dental pit/fissure sealant

Pit And Fissure Sealant Op by Five Star Orthodontic Laboratory & Supply, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K093059 also covers:

PIT AND FISSURE SEALANT CLEAR 4-1ML SYRINGES — FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, INC.

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 727d14a4-3191-4bb6-be32-0118eff338ab 33 fields · synced May 30, 2026