← Back to catalogue

Britedent

FDA UDI

Class I (US FDA UDI)

by Bright Supply Inc

Identity

Trade Name
Britedent FDA UDI
Generic Name
Dental material application tool, single-use FDA UDI
Device Name
Micro Applicators Regular (2.00mm) Blue FDA UDI
Model / Reference
BSI-2000 FDA UDI
Description
Micro Applicators Regular (2.00mm) Blue FDA UDI

Identifiers

Primary DI / UDI-DI
D974BSI20001 FDA UDI
FDA Product Code
KXR FDA UDI
GMDN Term
Dental material application tool, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.3140 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Dental material application tool, single-use

Britedent by Bright Supply Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental material application tool, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Bright Supply Inc

Sources (1)

  • FDA UDI 3be0f752-f26f-4c5e-b370-75da7b8d1edf 33 fields · synced May 30, 2026