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Air Solfy

FDA UDI

Class I (US FDA UDI)

by J.morita Mfg.corp.

Identity

Trade Name
AIR SOLFY FDA UDI
Generic Name
Pneumatic dental scaling/debridement system handpiece FDA UDI
Model / Reference
AS-2-O V FDA UDI

Identifiers

Primary DI / UDI-DI
04548213016631 FDA UDI
510(k) Number
K043497 FDA UDI
FDA Product Code
EFB FDA UDI
GMDN Term
Pneumatic dental scaling/debridement system handpiece 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

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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 scaling/debridement system handpiece

Air Solfy by J.morita Mfg.corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pneumatic dental scaling/debridement system handpiece.

Cleared under the same submission

K043497 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
J.morita Mfg.corp.

Sources (1)

  • FDA UDI 8884543a-79e7-4c60-a431-9dbfbd39b234 34 fields · synced May 30, 2026