FDA.reportPublic FDA data

Etchmaster

Primary DI
D798EMTRS1
Brand
Etchmaster
Company
RELIANCE ORTHODONTIC PRODUCTS INC
Model
EMTRS
Catalog number
EMTRS
Device description
The Etchmaster system is intended for use for polishing, roughening and/or etching of tooth surfaces, enamel, dentin, and dental restorations for adhesive restorative procedures. This is the Etchmaster Regular Small Tips
Published
2016-09-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
D798EMTRS2PackageHIBCC50In Commercial Distribution
D798EMTRS3PackageHIBCC100Not in Commercial Distribution
D798EMTRS1PrimaryHIBCC0
D798EMTRS0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Chairside dental abrasive air jet systemAn assembly of devices that comprises 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/teeth. It typically consists of a control unit, a dedicated intraoral handpiece and a foot switch that enables the dentist to control the abrasion process; some types are known as a sandblaster. It has a variety of applications such as, the removal of plaque and stains, cleaning fissures, the preparation of the tooth surface prior to bonding, the cleaning of orthodontic appliances (bands, brackets), the removal of adhesive residue and the cleaning of implants prior to loading.

Contacts#

Phone, Email table
PhoneEmail
6307734009paulgropi@aol.com

Regulatory Flags#

DUNS number
113170088
Device count
25
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D798EMHAPR0EtchmasterEMHAPR2021-07-13
D798ASK0ASKASKASK2016-07-25
D798ASKU0ASKASKUASKU2016-07-25
D798EMCO20EtchmasterEMCO2EMCO22016-09-09
D798EMGAS0EtchmasterEMGASEMGAS2016-09-03
D798EMHA0EtchmasterEMHAEMHA2016-09-03
D798EMHAR0EtchmasterEMHAREMHAR2016-09-04
D798EMTLL1EtchmasterEMTLLEMTLL2016-09-04
D798EMTLS1EtchmasterEMTLSEMTLS2016-09-04
D798EMTRL1EtchmasterEMTRLEMTRL2016-09-04
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04560264548459Powder Handpiece(For Prophy use)NAKANISHI INC.KOJ2026-06-11
04560264548473Powder Handpiece(For Perio use)NAKANISHI INC.KOJ2026-06-11
04560264579538CLM Bottole SetNAKANISHI INC.KOJ2026-06-11
04560264579569CLM HolderNAKANISHI INC.KOJ2026-06-11
04589551391202Prophy Kit2NAKANISHI INC.KOJ2026-06-11
04589551391219Perio Kit2NAKANISHI INC.KOJ2026-06-11
04589551395095Varios Combi Pro2 Basic SetNAKANISHI INC.KOJ2026-06-11
04589551395323CLM Module SetNAKANISHI INC.KOJ2026-06-11
04589551395347Water Bottle KitNAKANISHI INC.KOJ2026-06-11
04589551395439FC-83NAKANISHI INC.KOJ2026-06-11
00840479200774ALL SURFACE KITRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-04-03
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
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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