Taper Drill

FDA UDI

Class I (US FDA UDI)

by OSSTEM IMPLANT Co., Ltd.

Identity

Trade Name: Taper Drill FDA UDI
Generic Name: Fixture/appliance dental drill bit, reusable FDA UDI
Model / Reference: HTPD3C5511 FDA UDI

Identifiers

Primary DI / UDI-DI: 08800271218546 FDA UDI
FDA Product Code: DZA FDA UDI
GMDN Term: Fixture/appliance dental drill bit, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4130 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

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Lot / Batch Number

Yes

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Serial Number

Yes

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Expiration Date

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Manufacturing Date

Yes

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Fixture/appliance dental drill bit, reusable

A comprehensive 2-3 paragraph SEO description written in clear, natural language. The Taper Drill is a versatile dental device designed for creating channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance.

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Also classified as Fixture/appliance dental drill bit, reusable.

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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: OSSTEM IMPLANT Co., Ltd.

Sources (1)

FDA UDI 2e1f6f66-cd7e-447a-aaef-80788248d1a5 32 fields · synced Jul 30, 2026