FDA.reportPublic FDA data

BenTips Mod Tri A3

Primary DI
D966T15V501
Brand
BenTips Mod Tri A3
Company
BENNETT JACOBY, DDS, MS, INC.
Model
T15v5.0
Published
2022-02-17
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
D966T15V501PrimaryHIBCC0
D966T15V500Unit of UseHIBCC0

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
100
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
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
D966WPUP6A0BenTips Insert WPUP6AWPUP6A2021-08-17

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Primary DI, Brand, Company table
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07613327652741N/ASTRYKER CORPORATIONDZI2026-03-25
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