FDA.reportPublic FDA data

BenTips Piezosurgery Unit

Primary DI
D966BPS1LED0
Brand
BenTips Piezosurgery Unit
Company
BENNETT JACOBY, DDS, MS, INC.
Model
BPS1LED
Device description
BenTips Piezosurgery Control Unit
Published
2021-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DZIDrill, Bone, Powered
ELCScaler, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZIDrill, Bone, PoweredDental2
ELCScaler, UltrasonicDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111290000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111290000PIEZO BONE SURGERYGuilin Woodpecker Medical Instrument Co., Ltd.2011-11-18DZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D966BPS1LED0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental ultrasonic surgical system generatorA mains electricity (AC-powered) component of a dental ultrasonic surgical system used to generate a high frequency electrical current that is converted, typically within a handpiece, into an ultrasonic oscillation to mechanically fragment and cut bone upon contact with a vibrating tip during dental surgery, typically in combination with irrigation. It provides the controls and monitoring functions for the system during the procedure, and typically regulates energy to the system via a foot-switch.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
031283428
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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D966T15V501BenTips Mod Tri A3T15v5.02022-02-17
D966T16V301BenTips Star A3T16v3.02022-02-17
D966T18V241BenTips OG Quad AT18v2.42022-02-17
D966TTA1BenTips TTATTA2022-02-17
D966T15V330BenTips Stubby Tri A3T15v3.32022-02-17
D966T15V500BenTips Mod Tri A3T15v5.02022-02-17
D966T16V300BenTips Star A3T16v3.02022-02-17
D966T18V240BenTips OG Quad AT18v2.42022-02-17
D966TTA0BenTips TTATTA2022-02-17
D966S45AV10BenTips Shaft 45Av1S45Av12021-11-01
D966S90AV10BenTips Shaft 90Av1S90Av12021-11-01
D966WPUI3A0BenTips Insert WPUI3AWPUI3A2021-08-17
D966WPUI4A0BenTips Insert WPUI4AWPUI4A2021-08-17
D966WPUI5A0BenTips Insert WPUI5AWPUI5A2021-08-17
D966WPUI6A0BenTips Insert WPUI6AWPUI6A2021-08-17
D966WPUI7A0BenTips Insert WPUI7AWPUI7A2021-08-17
D966WPUP2A0BenTips Insert WPUP2AWPUP2A2021-08-17
D966WPUP3A0BenTips Insert WPUP3AWPUP3A2021-08-17
D966WPUP4A0BenTips Insert WPUP4AWPUP4A2021-08-17

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Primary DI, Brand, Company table
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