FDA.reportPublic FDA data

BenTips Piezosurgery System

Primary DI
D966B10
Brand
BenTips Piezosurgery System
Company
BENNETT JACOBY, DDS, MS, INC.
Model
B1
Device description
BenTips Piezosurgery System including: 1 control unit, 2 handpieces, 1 foot pedal, 1 power cord and other accessories.
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
D966B10PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental ultrasonic surgical systemAn assembly of devices that converts high frequency current into ultrasonic oscillation to mechanically fragment and cut bone upon contact with a vibrating tip during dental surgery, typically in combination with irrigation. It typically includes an energy-producing generator with monitoring functions, a handpiece(s) with tip(s) to convert and apply the energy, connecting cables, and a foot-switch to regulate the energy. It is used for implant-site preparation, dental extraction, distraction, sinus lift, periodontal surgery, cyst removal, extraction of bone block, bone harvesting, osteoplasty and osteotomy.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
031283428
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D966T15V331BenTips Stubby Tri A3T15v3.32022-02-17
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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04560264501935VA750-SCNAKANISHI INC.ELC2026-10-01
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04560264501980Water Filter Set (2m)NAKANISHI INC.ELC2026-10-01
04560264503649VA560LUX-SCNAKANISHI INC.ELC2026-10-01
04560264519022VA970-SCNAKANISHI INC.ELC2026-10-01
04560264519039VA970LUX-SCNAKANISHI INC.ELC2026-10-01
04560264522510VA570-SCNAKANISHI INC.ELC2026-10-01
04560264522527VA570LUX-SCNAKANISHI INC.ELC2026-10-01
04560264535213Water Filter Set (4m)NAKANISHI INC.ELC2026-10-01
06979865810038JAS MotorDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810045JAS FillDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810052JAS PexDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810069JAS ActivatorDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810076JAS Charging UnitDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810083JAS Contra-AngleDENJOY DENTAL CO.,LTDELC2026-09-24
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06979865810175JAS Unit Endo SystemDENJOY DENTAL CO.,LTDELC2026-09-24
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07613353318581AIRFLOW Prophylaxis MasterE.M.S. Electro Medical Systems S.A.ELC2026-07-14
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