FDA.reportPublic FDA data

ALL SURFACE KIT

Primary DI
00840479200774
Brand
ALL SURFACE KIT
Company
RELIANCE ORTHODONTIC PRODUCTS INC
Model
ASK
Published
2026-04-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KOJAirbrush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOJAirbrushDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030292000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030292000GROMAN PREPMASTERGroman, Inc.2003-04-15KOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D798ASK0PreviousHIBCC0
00840479200774PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840479200774008404792007748404792007740840479200774

GMDN Terms#

Term, Definition table
TermDefinition
Dental material injection cannula, single-useA rigid or semi-rigid luminal device (dental tip) intended to channel and dispense a dental material/solution [e.g., restorative amalgam, resin, etching solution (etchant), topical dental anaesthetic] from a dental syringe, or similar applicator, to a patient’s teeth, oral mucosa, or gums; it is not intended to penetrate tissue (it is not a needle), not dedicated to root canal irrigation, and may be used for dental applications outside the patients mouth. This is a single-use device.

Regulatory Flags#

DUNS number
113170088
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D798USEP0Ultra SEPUSEP2022-03-03
D798PPA10Perfect A SmilePPA1PPA12019-09-10
D798PPD30Perfect A SmilePPD3PPD32019-09-10
D798EL240EtchantEL24EL242016-08-10
D798EL24C0EtchantEL24CEL24C2016-08-10
D798LBMPPF0LIGHT BONDLBMPPFLBMPPF2016-08-03
D798LBPP0Light BondLBPPLBPP2016-08-03
D798LBS30Light BondLBS3LBS32016-08-03
D798LBS3F0Light BondLBS3FLBS3F2016-08-06
D798LBTPP0Light BondLBTPPLBTPP2019-01-14
D798MC20AF0Maximum CureMC20AFMC20AF2016-08-10
D798OFT20Ortho FlexTechOFT2OFT22016-08-06
D798OFTSAM0Ortho FlexTechOFTOFT2018-04-13
D798PO0Porcelain ConditionerPOPO2016-08-15
D798PPA20Perfect A SmilePPA2PPA22016-08-06
D798RSPFG1RenewRSPFGRSPFG2016-09-04
D798TC0Therma CureTCTC2016-07-27
D798UBLBPP0Ultra Band LokUBLBPPUBLBPP2016-07-25
D798UBLPP0Ultra Band LokUBLPPUBLPP2016-07-25
D7981FTLV0Flow Tain1FTLV1FTLV2020-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840479201191ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
00840479201207ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
00840479201214ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
00840479201245ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
00840479201252ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
00840479201269ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
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
10889950142636Subgingival PWR Perio TipsHU-FRIEDY MFG. CO., LLCKOJ2024-07-17