FDA.reportPublic FDA data

Johnson-Promident

Primary DI
10816577023451
Brand
Johnson-Promident
Company
Young Innovations, Inc.
Model
519900
Catalog number
519900
Device description
JETPOLISHER 2000 AIR POLISHING UNIT KAVO TYPE CONNECTOR
Published
2022-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
10816577023451PackageGS11In Commercial Distribution
00816577023454PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081657702345110816577023451
00816577023454008165770234548165770234540816577023454

GMDN Terms#

Term, Definition table
TermDefinition
Dental abrasive air jet system handpieceA hand-held, dental device that is a component of a dental abrasive air jet system and which is 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. This device is connected to the control unit that regulates the sources of pressurized air and temperate water. The abrasive, typically in the form of a powder that, depending upon the design of the delivery method, can be contained within a receptacle in this device or a receptacle within the control unit, is mixed with the air and water as this passes through. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 210-8945customerservice@younginnovations.com

Regulatory Flags#

DUNS number
004193103
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840326426630Astek1002991002992026-05-11
00840326423851Astek19025190252025-03-17
00840326423868Astek19026190262025-03-17
00840326423875Astek19027190272025-03-17
00840326423882Astek19028190282025-03-17
00843471150061Astek19000190002022-10-18
00843471150078Astek19005190052022-10-18
00843471150085Astek19001190012022-10-18
00843471150092Astek19006190062022-10-18
00840326426586Plak Smacker2000622026-04-20
00840326426593Plak Smacker2000632026-04-20
00840326426609Plak Smacker2000642026-04-20
00840326426616Plak Smacker2000652026-04-20
00840326426623Plak Smacker2000662026-04-20
00840326426203Young Specialties2000-02-102000-02-102026-01-26
00840326426210Young Specialties2000-03-102000-03-102026-01-26
00840326426227Young Specialties2000-04-102000-04-102026-01-26
00840326426234Young Specialties2000-05-102000-05-102026-01-26
00840326426241Young Specialties2000-06-102000-06-102026-01-26
00840326426258Young Specialties2000-07-102000-07-102026-01-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10889950154066PWR AirHU-FRIEDY MFG. CO., LLCKOJ2026-01-14
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07613353257866AIR-FLOWE.M.S. Electro Medical Systems S.A.KOJ2025-10-20
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06944843611594DTEGuilin Woodpecker Medical Instrument Co., Ltd.KOJ2024-10-18
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06944843611617DTEGuilin Woodpecker Medical Instrument Co., Ltd.KOJ2024-10-18
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10889950142551PWR PairHU-FRIEDY MFG. CO., LLCKOJ2024-07-17