Alpen Diamond Instruments

FDA UDI

Class I (US FDA UDI)

by Coltène/Whaledent AG

Identity

Trade Name: Alpen Diamond Instruments FDA UDI
Generic Name: Diamond dental bur, reusable FDA UDI
Model / Reference: R856TC018FG FDA UDI

Identifiers

Catalog Number: R856TC018FG FDA UDI
Primary DI / UDI-DI: J006R856TC018FG0 FDA UDI
FDA Product Code: DZP FDA UDI
GMDN Term: Diamond dental bur, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4535 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Diamond dental bur, reusable

Alpen Diamond Instruments by Coltène/Whaledent AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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MAXCUT DIAMOND BURS (6/pk) CRS 6852-012 — SCOTT'S DENTAL SUPPLY L.L.C. · Class I
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HORICO — Hopf, Ringleb & Co. GmbH & Cie. · Class I
Sunshine Diamonds — Dr. Hopf GmbH & Co. KG · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Coltène/Whaledent AG

Sources (1)

FDA UDI a40ab544-a3f5-45d5-bf52-f1fba91ee971 34 fields · synced Jun 6, 2026