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Robot Point

FDA UDI

Class I (US FDA UDI)

by Shofu Dental Corp.

Identity

Trade Name
ROBOT POINT FDA UDI
Generic Name
Diamond dental bur, reusable FDA UDI
Device Name
FG ROBOT POINT 1 PIECE FDA UDI
Model / Reference
832F-1 FDA UDI
Description
FG ROBOT POINT 1 PIECE FDA UDI

Identifiers

Catalog Number
832F-1 FDA UDI
Primary DI / UDI-DI
E235832F10 FDA UDI
FDA Product Code
DZP FDA UDI
GMDN Term
Diamond dental bur, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4535 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

Yes

FDA UDI

Lot / Batch Number

Yes

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: Diamond dental bur, reusable

Robot Point by Shofu Dental Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diamond dental bur, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shofu Dental Corp.

Sources (1)

  • FDA UDI b9ba0ee1-ae24-4d40-bd52-d106fa5a5056 35 fields · synced May 31, 2026