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SABLE Rotamax PRO 45

FDA UDI

Class I (US FDA UDI)

by Sable Industries Inc

Identity

Trade Name
SABLE Rotamax PRO 45 FDA UDI
Generic Name
Dental surgical power tool motorized handpiece/set, pneumatic FDA UDI
Device Name
Sable Rotamax PRO 45 is a 45 degree push button 4-hole fixed back end High Speed Handpiece FDA UDI
Model / Reference
2000024 FDA UDI
Description
Sable Rotamax PRO 45 is a 45 degree push button 4-hole fixed back end High Speed Handpiece FDA UDI

Identifiers

Primary DI / UDI-DI
00841359010063 FDA UDI
510(k) Number
K072554 FDA UDI
FDA Product Code
EFB FDA UDI
GMDN Term
Dental surgical power tool motorized handpiece/set, pneumatic 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 surgical power tool motorized handpiece/set, pneumatic

SABLE Rotamax PRO 45 by Sable Industries Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental surgical power tool motorized handpiece/set, pneumatic.

Cleared under the same submission

K072554 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sable Industries Inc

Sources (1)

  • FDA UDI 3f3c4cc8-3532-422a-8630-c14f3327def2 35 fields · synced May 30, 2026