BenTips Piezosurgery Unit

GUDID D966BPS1LED0

BenTips Piezosurgery Control Unit

BENNETT JACOBY, DDS, MS, INC.

Dental ultrasonic surgical system generator
Primary Device IDD966BPS1LED0
NIH Device Record Key52a6d109-4ee6-4b62-a025-5451fa0affce
Commercial Distribution StatusIn Commercial Distribution
Brand NameBenTips Piezosurgery Unit
Version Model NumberBPS1LED
Company DUNS031283428
Company NameBENNETT JACOBY, DDS, MS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD966BPS1LED0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZIDrill, Bone, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-09
Device Publish Date2021-04-01

Devices Manufactured by BENNETT JACOBY, DDS, MS, INC.

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D966T16V300 - BenTips Star A32022-02-25
D966T18V240 - BenTips OG Quad A2022-02-25
D966TTA0 - BenTips TTA2022-02-25 T15v1.1
D966S45AV10 - BenTips Shaft 45Av12021-11-09 BenTips shaft designed and configured to connect the piezosurgery handpiece to the PEEK tips.
D966S90AV10 - BenTips Shaft 90Av12021-11-09 BenTips shaft designed and configured to connect the piezosurgery handpiece to the PEEK tips.
D966WPUI3A0 - BenTips Insert WPUI3A2021-08-25 BenTips Insert WPUI3A

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