Aw-100

FDA UDI

Class II (US FDA UDI)

by Micron Corp.

Identity

Trade Name: AW-100 FDA UDI
Generic Name: Pneumatic dental scaling/debridement system FDA UDI
Model / Reference: AW-100-KA FDA UDI

Identifiers

Primary DI / UDI-DI: 04560205916569 FDA UDI
510(k) Number: K171150 FDA UDI
FDA Product Code: ELC FDA UDI
GMDN Term: Pneumatic dental scaling/debridement system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.4850 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

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Pneumatic dental scaling/debridement system

Aw-100 by Micron Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Pneumatic dental scaling/debridement system.

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Vivid Max Sonic Scaler W/3 Tips — PEARSON DENTAL SUPPLIES, INC.
StarDental Instrument Solutions — DENTALEZ, INC. · Class II
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ZA-55 Scaler B.F. A-dec — W & H Dentalwerk Bürmoos GmbH · Class II

Cleared under the same submission

K171150 also covers:

AW-100 — Micron Corp.

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 II	Pending data

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Manufacturer

Manufacturer: Micron Corp.

Sources (1)

FDA UDI 656a98f6-5346-4eae-8507-a2c1c7e24943 33 fields · synced Jun 8, 2026