Clone Bite

FDA UDI

Class II (US FDA UDI)

by Ultradent Products, Inc.

Identity

Trade Name: Clone Bite FDA UDI
Generic Name: Dental pit/fissure sealant FDA UDI
Device Name: Clone Bite Kit FDA UDI
Model / Reference: 7600 FDA UDI
Description: Clone Bite Kit FDA UDI

Identifiers

Catalog Number: 7600 FDA UDI
Primary DI / UDI-DI: 00883205107800 FDA UDI
510(k) Number: K024034 FDA UDI
FDA Product Code: ELW FDA UDI
GMDN Term: Dental pit/fissure sealant FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3660 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

Yes

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: Dental pit/fissure sealant

Clone Bite by Ultradent Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Dental pit/fissure sealant.

ICE — Sdi , Ltd. · Class II
ICE — Sdi , Ltd. · Class II
PREVENT SEAL — ITENA CLINICAL · Class II
AURA — Sdi , Ltd. · Class II
GLACIER — Sdi , Ltd. · Class II
SciPharm Pit & Fissure Sealer Bonding Agent — SCIENTIFIC PHARMACEUTICALS, INC. · Class II
Seal-Rite™ Low Viscosity — Pulpdent Corporation · Class II
GLACIER — Sdi , Ltd. · Class II

Cleared under the same submission

K024034 also covers:

Chromaclone — ULTRADENT PRODUCTS, 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: Ultradent Products, Inc.

Sources (1)

FDA UDI f6b0d424-f263-419b-a142-f19ce2c0a634 37 fields · synced May 30, 2026