MicroAire®

FDA UDI

Class I (US FDA UDI)

by MicroAire Surgical Instruments LLC

Identity

Trade Name: MicroAire® FDA UDI
Generic Name: Fixture/appliance dental drill bit, single-use FDA UDI
Device Name: SST TWIST DRILL, DENTAL, 2mm Dia. x 65mm FDA UDI
Model / Reference: 8051-020 FDA UDI
Description: SST TWIST DRILL, DENTAL, 2mm Dia. x 65mm FDA UDI

Identifiers

Primary DI / UDI-DI: 00847399004987 FDA UDI
FDA Product Code: HTW FDA UDI
GMDN Term: Fixture/appliance dental drill bit, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 2 Millimeter FDA UDI
Length — 65 Millimeter FDA UDI

Category: Fixture/appliance dental drill bit, single-use

MicroAire® by MicroAire Surgical Instruments LLC — 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: MicroAire Surgical Instruments LLC

Sources (1)

FDA UDI 2275d1cb-1fdd-477d-a532-75488b144936 34 fields · synced Jun 9, 2026