FDA.reportPublic FDA data

Patterson®

Primary DI
D6620704115790
Brand
Patterson®
Company
PATTERSON DENTAL SUPPLY, INC.
Model
70411579
Catalog number
70411579
Device description
AGENT, TOOTH BONDING, RESIN
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KLEAgent, Tooth Bonding, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLEAgent, Tooth Bonding, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082753000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082753000FUTURABOND M/FUTURABOND M SINGLE DOSEVoco GmbH2008-11-24KLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D6620704115790PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental abrasive powderA dental material made from various base substances having some abrasive qualities [e.g., treated sodium bicarbonate (NaHCO3) or aluminium oxide (Al2O3)] and applied with an appropriate device (e.g., a dental abrasive air jet system) to the surface of teeth or dental devices. It has a wide variety of both prophylactic and treatment applications such as the removal of plaque and stains, cleaning fissures (above and below the gingiva), the preparation of a tooth surface prior to bonding, the cleaning of orthodontic appliances (bands and brackets), the removal of adhesive residue, and the cleaning of implants prior to loading. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
171843584
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D6620708296480PATTERSON0708296482018-09-18
D6620708394560PATTERSON0708394562018-09-18
D6620708996740PATTERSON 089-96742015-09-25
D6620708325012PATTERSON0708325012016-09-23
D6620708325192PATTERSON0708325192016-09-23
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
D6620708507502Patterson®70850750708507502016-09-23
D6620708508002Patterson®70850800708508002016-09-23
D6620703523022Patterson®70352302703523022016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00197998024269Solventum™Solventum Germany GmbHKLE2026-05-08
00197998024276Solventum™Solventum Germany GmbHKLE2026-05-08
00197998024290Solventum™Solventum Germany GmbHKLE2026-05-08
J017CVMLP0140VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
J017CVMLP0240VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
J017CVMLPSET0VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
08809262954012FineEtchSpident Co., Ltd.KLE2026-04-20
08809262954029FineEtchSpident Co., Ltd.KLE2026-04-20
306058610668163M™ Adper™ Scotchbond™3M COMPANYKLE2026-04-17
306058610669083M™ Adper™ Scotchbond™3M COMPANYKLE2026-04-17
506058610362573M™ Adper™3M COMPANYKLE2026-04-17
D0019064140LucitoneDentsply International Inc.KLE2025-07-01
D0019064150LucitoneDentsply International Inc.KLE2025-07-01
D0019064160LucitoneDentsply International Inc.KLE2025-07-01
D0019064170LucitoneDentsply International Inc.KLE2025-07-01
00359883004446MPa™ Max Adhesive with Chlorhexidine KitDEN-MAT HOLDINGS, LLCKLE2025-03-12
00195062068508OptiBond Universal 360Kerr CorporationKLE2024-06-25
07615208298536Monobond PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2024-01-24
D0019064020LucitoneDentsply International Inc.KLE2023-11-14
D0019064030LucitoneDentsply International Inc.KLE2023-11-14
D0019064040LucitoneDentsply International Inc.KLE2023-11-14
D0019064050LucitoneDentsply International Inc.KLE2023-11-14
07615208293128Adhese 100IVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208295375Monobond Etch & PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208296136Adhese UniversalIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208296143Adhese UniversalIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208297362ExciTE FIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208297379ExciTE FIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06