FDA.reportPublic FDA data

BenTips Shaft 90Av1

Primary DI
D966S90AV10
Brand
BenTips Shaft 90Av1
Company
BENNETT JACOBY, DDS, MS, INC.
Model
S90Av1
Device description
BenTips shaft designed and configured to connect the piezosurgery handpiece to the PEEK tips.
Published
2021-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
K192033000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192033000Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad TipBennett Jacoby, Dds, Ms, Inc.2020-06-09DZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D966S90AV10PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic dental scaling/debridement system handpiece tip, periodontalAn insert intended to be attached to an ultrasonic dental scaling/debridement system handpiece, to transmit ultrasonic energy (e.g., 25 kHz/30 kHz) from a generator to the oral cavity for the removal of accretions from tooth surfaces during dental cleaning or periodontal therapy; it is not intended for endodontic use. This device vibrates at a high frequency to provide the scaling effect. Water or a rinsing solution (e.g., chlorhexidine) is intended to be fed through the handpiece/tip assembly to assist in the process. This device is available in a variety of designs and tip shapes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
031283428
Device count
1
DM exempt
true
Lot or batch
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
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
D966WPUP6A0BenTips Insert WPUP6AWPUP6A2021-08-17

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Primary DI, Brand, Company table
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04560264535213Water Filter Set (4m)NAKANISHI INC.ELC2026-10-01
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