FDA.reportPublic FDA data

Britedent

Primary DI
D974BSI0027L10
Brand
Britedent
Company
Bright Supply, Inc.
Model
BSI-0027L
Device description
Irrigation Dental Needles 27G/Long 0.4mm x 30mm
Published
2024-02-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DZMNeedle, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZMNeedle, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D974BSI0027L1PrimaryHIBCC0
D974BSI0027L10Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe/needleA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a non-retractable needle is included, either attached or detached (usually capped for user protection). It is intended for various medical applications and is not dedicated to medication administration. The syringe is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
124117012
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D974BSI20031BritedentBSI-20032024-06-07
D974BSI55001BritedentBSI-55002025-08-21
D974BSI55002BritedentBSI-55002025-08-21
D974BSI29111BritedentBSI-29112025-03-11
D974BSI29112BritedentBSI-29112025-03-11
D974BSI01021BritedentBSI-01022020-11-26
D974BSI01031BritedentBSI-01032021-07-31
D974BSI01051BritedentBSI-01052021-08-12
D974BSI25031BritedentBSI-25032023-07-28
D974BSI25041BritedentBSI-25042024-01-18
D974BSI25051BritedentBSI-25052022-03-18
D974BSI25071BritedentBSI-25072021-12-31
D974BSI29011BritedentBSI-29012021-03-30
D974BSI29031BritedentBSI-29032021-04-22
D974BSI29051BritedentBSI-29052021-04-22
D974BSI29061BritedentBSI-29062021-04-22
D974BSI29091BritedentBSI-29092021-03-30
D974BSI29101BritedentBSI-29102021-06-28
D974BSI29121BritedentBSI-29122021-04-22
D974BSI29131BritedentBSI-29132021-06-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08053610773750EFFITECDENTALHITECDZM2026-08-06
08053610773781EFFITECTECNOFAR SPADZM2026-07-30
08053610773798EFFITECTECNOFAR SPADZM2026-07-30
08053610773804EFFITECTECNOFAR SPADZM2026-07-30
06973042242834Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242841Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242865Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242872Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242889Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242896Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242902Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242919Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242926Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242933Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242940Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242957Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242964Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242971Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242988Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-10
06973042242674Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242681Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242698Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242704Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242711Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242728Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242735Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242742Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242759Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242766Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242780Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09