Tapered Drill 3.45X23 - Green

FDA UDI

Class I (US FDA UDI)

by 3d Diagnostix, Inc.

Identity

Trade Name: Tapered Drill 3.45X23 - Green FDA UDI
Generic Name: Fixture/appliance dental drill bit, reusable FDA UDI
Device Name: Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance. FDA UDI
Model / Reference: Dental Drill bit, reusable / Tapered Drill 3.45X23 - Green FDA UDI
Description: Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance. FDA UDI

Identifiers

Primary DI / UDI-DI: 00850073333464 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Fixture/appliance dental drill bit, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3980 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

Dry Heat Sterilization FDA UDI

Category: Fixture/appliance dental drill bit, reusable

Tapered Drill 3.45X23 - Green by 3d Diagnostix, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: 3d Diagnostix, Inc.

Sources (1)

FDA UDI c20bd3eb-f27c-4739-929a-be99ab3ff9ac 33 fields · synced May 29, 2026