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Power Dental USA

FDA UDI

Class I (US FDA UDI)

by Power Dental USA, Inc.

Identity

Trade Name
Power Dental USA FDA UDI
Generic Name
Ultrasonic dental scaling/debridement system handpiece tip, periodontal FDA UDI
Device Name
LATERAL APPROACH REAMER 2.7mm ROUND HANDPIECE USE FDA UDI
Model / Reference
8120-13 FDA UDI
Description
LATERAL APPROACH REAMER 2.7mm ROUND HANDPIECE USE FDA UDI

Identifiers

Catalog Number
8120-13 FDA UDI
Primary DI / UDI-DI
D943812013 FDA UDI
FDA Product Code
MDM FDA UDI
GMDN Term
Ultrasonic dental scaling/debridement system handpiece tip, periodontal FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dressing/utility forceps, scissors-like, reusableUltrasonic dental scaling/debridement system handpiece tip, periodontal

Power Dental USA by Power Dental USA, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ultrasonic dental scaling/debridement system handpiece tip, periodontal.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Power Dental USA, Inc.

Sources (1)

  • FDA UDI c8807c1f-2f54-4cf0-9ffc-339f61ce31cb 35 fields · synced May 31, 2026