Britedent

FDA UDI

Class I (US FDA UDI)

by Bright Supply Inc

Identity

Trade Name: Britedent FDA UDI
Generic Name: Dental material injection cannula, single-use FDA UDI
Device Name: Prebent Dispensing Tips 21G Green FDA UDI
Model / Reference: BSI-1021 FDA UDI
Description: Prebent Dispensing Tips 21G Green FDA UDI

Identifiers

Primary DI / UDI-DI: D974BSI10211 FDA UDI
FDA Product Code: EIB FDA UDI
GMDN Term: Dental material injection cannula, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Dental material injection cannula, 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 injection cannula, single-use.

Clinician's Choice® Needle Tubes & Plugs — Den-Mat Holdings, LLC · Class I
PRIME|ONE — Akzenta International SA · Class I
NaviTip Tips — ULTRADENT PRODUCTS, INC. · Class I
CanalPro™ Color Syringes — Coltène/Whaledent AG · Class I
RelyX™ Unicem 2 Automix — 3M Deutschland GmbH · Class I
Avalon Biomed NeoSEALER 20 Flex Flo Tips — NUSMILE, LTD · Class I
EDS Mixing Tips — ESSENTIAL DENTAL SYSTEMS, INC. · Class I
PRIME|ONE — Akzenta International SA · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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

Manufacturer

Manufacturer: Bright Supply Inc

Sources (1)

FDA UDI a874f0da-ef08-45d4-b2d4-4cf7f7424474 33 fields · synced Jun 8, 2026