FDA.reportPublic FDA data

Patterson®

Primary DI
D6620709785022
Brand
Patterson®
Company
PATTERSON DENTAL SUPPLY, INC.
Model
70978502
Catalog number
70978502
Device description
DENTAL HANDPIECE AND ACCESSORY
Published
2024-05-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EFBHandpiece, air-powered, dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFBHandpiece, Air-Powered, DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K963664000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K963664000DENTAL HANDPIECE AND ACCESSORYFilmtech, Inc.1996-10-24EFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D6620709785022PrimaryHIBCC0
D6620709785020Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Root canal irrigation handpieceA hand-operated, air-powered, dental instrument used for the irrigation of prepared root canals to provide thorough debridement of the canal space. It is connected to an air supply via a pressure hose to activate its internal pump mechanism which injects a root canal cleanser via a thin disposable needle into the canal space. This device replaces time consuming manual syringe irrigation and is used for the elimination of pulpal tissue, necrotic materials, and bacteria from the instrumented root canal. This is a reusable device.

Regulatory Flags#

DUNS number
171843584
Device count
300
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D66207043102302Patterson®043-1023704310232024-11-11
D6620704340920Patterson®043-4092704340922024-11-11
D6620708296480PATTERSON0708296482018-09-18
D6620708394560PATTERSON0708394562018-09-18
D6620708996740PATTERSON 089-96742015-09-25
D6620708325012PATTERSON0708325012016-09-23
D6620708325192PATTERSON0708325192016-09-23
D6620704115790Patterson®70411579704115792016-09-23
D6620708903840Patterson®70890384708903842016-09-23
D66207111063405Patterson®71110634711106342024-05-08
D6620711869150Patterson®71186915711869152024-05-08
D6620711869310Patterson®71186931711869312024-05-08
D6620714708480Patterson®25-PAT714708482025-02-06
D6620714708550Patterson®15-PAT714708552025-02-06
D6620714708630Patterson®65-PAT714708632025-02-06
D6620714708710Patterson®204-PAT714708712025-02-06
D6620714708890Patterson®57-PAT714708892025-02-06
D6620714969590Patterson®22-PAT714969592025-02-06
D6620708506692Patterson®70850669708506692016-09-23
D6620708506932Patterson®70850693708506932016-09-23

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