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Prophy-Mate neo

FDA UDI

Class I (US FDA UDI)

by Nakanishi Inc.

Identity

Trade Name
Prophy-Mate neo FDA UDI
Generic Name
Dental abrasive air jet system handpiece FDA UDI
Model / Reference
PMNG-M4 FDA UDI

Identifiers

Primary DI / UDI-DI
04560264572478 FDA UDI
510(k) Number
K112673 FDA UDI
FDA Product Code
EFB FDA UDI
GMDN Term
Dental abrasive air jet 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

No

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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental abrasive air jet system handpiece

Prophy-Mate neo by Nakanishi Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental abrasive air jet system handpiece.

Cleared under the same submission

K112673 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nakanishi Inc.

Sources (1)

  • FDA UDI a5a11314-e4cd-475d-9518-98a2b27f17c1 33 fields · synced Jun 8, 2026