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A-dec

FDA UDI

Class I (US FDA UDI)

by A-Dec, Inc.

Identity

Trade Name
A-dec FDA UDI
Generic Name
Pneumatic dental power tool system handpiece tip, reusable FDA UDI
Device Name
Air HS Package,M8900L,Master Torque,OTC FDA UDI
Model / Reference
54.0875.00 FDA UDI
Description
Air HS Package,M8900L,Master Torque,OTC FDA UDI

Identifiers

Catalog Number
54.0875.00 FDA UDI
Primary DI / UDI-DI
10194665004477 FDA UDI
510(k) Number
K130560 FDA UDI
FDA Product Code
EFB FDA UDI
GMDN Term
Pneumatic dental power tool system handpiece tip, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Pneumatic dental power tool system handpiece tip, reusable

A-dec by A-Dec, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pneumatic dental power tool system handpiece tip, reusable.

Cleared under the same submission

K130560 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
A-Dec, Inc.

Sources (1)

  • FDA UDI db17921e-bacc-41b1-b36e-80f32542d7e9 35 fields · synced May 31, 2026