FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040007464
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
9004192
Catalog number
9004192
Device description
Minipolisher Handpiece
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KOJAIRBRUSH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOJAirbrushDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K014249000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K014249000JETPOLISHERDeldent , Ltd.2002-02-19KOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00304040007464PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040007464003040400074643040400074640304040007464

GMDN Terms#

Term, Definition table
TermDefinition
Dental abrasive air jet systemAn assembly of devices that together comprise a dental abrasive air jet system used to direct a concentrated jet of air combined with an abrasive powder, together with water for cooling, to the surface of the patient's tooth or teeth. It typically consists of a control unit, a dedicated handpiece and a foot switch that enables the dentist to control the abrasion process. It has a wide variety of applications such as, the removal of plaque and stains, cleaning fissures (above and below the gingival), the preparation of the 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight83Gram

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14
10304040197018Henry Schein570586857058682026-05-14
10304040059446Henry Schein900445490044542019-02-13
10304040196790Henry Schein570584657058462026-04-21
10304040196806Henry Schein570584957058492026-04-21
10304040196660Henry Schein570583757058372026-04-17
10304040196677Henry Schein570583857058382026-04-17
10304040196684Henry Schein570583957058392026-04-17
10304040196691Henry Schein570584057058402026-04-17
10304040196707Henry Schein570584157058412026-04-17
10304040196714Henry Schein570584257058422026-04-17
10304040196653Henry Schein570583157058312026-04-10
00304040000236Henry Schein100-7773100-77732015-09-25
10304040119034Henry Schein570163357016332020-02-05
10304040119058Henry Schein570163457016342020-02-05
10304040119065Henry Schein570163657016362020-02-05
10304040119089Henry Schein570163857016382020-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840479201276ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
00840479201283ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
00840479201290ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
00840479201306ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
00840479201313ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
00840479202587ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
07613353225940GBT FLOWCONTROL x 4E.M.S. Electro Medical Systems S.A.KOJ2026-02-16
07613353313500GBT Machine StationE.M.S. Electro Medical Systems S.A.KOJ2026-02-16
07613353331184GBT Machine Wireless PedalE.M.S. Electro Medical Systems S.A.KOJ2026-02-16
07613353334925AIR-FLOWE.M.S. Electro Medical Systems S.A.KOJ2026-02-16
07613353348137AIR-FLOWE.M.S. Electro Medical Systems S.A.KOJ2026-02-16
10889950154066PWR AirHU-FRIEDY MFG. CO., LLCKOJ2026-01-14
10889950154080HuFriedyGroupHU-FRIEDY MFG. CO., LLCKOJ2026-01-14
10889950154103HuFriedyGroupHU-FRIEDY MFG. CO., LLCKOJ2026-01-14
07613353257866AIR-FLOWE.M.S. Electro Medical Systems S.A.KOJ2025-10-20
07613353334932AIR-FLOWE.M.S. Electro Medical Systems S.A.KOJ2025-07-07
06944843611587woodpeckerGuilin Woodpecker Medical Instrument Co., Ltd.KOJ2024-10-18
06944843611594DTEGuilin Woodpecker Medical Instrument Co., Ltd.KOJ2024-10-18
06944843611600woodpeckerGuilin Woodpecker Medical Instrument Co., Ltd.KOJ2024-10-18
06944843611617DTEGuilin Woodpecker Medical Instrument Co., Ltd.KOJ2024-10-18
06944843655987DTEGuilin Woodpecker Medical Instrument Co., Ltd.KOJ2024-10-18
06944843616872LOVE HYGIENEGuilin Woodpecker Medical Instrument Co., Ltd.KOJ2024-08-09
10889950142551PWR PairHU-FRIEDY MFG. CO., LLCKOJ2024-07-17