FDA.reportPublic FDA data

Etchmaster

Primary DI
00817494020144
Brand
Etchmaster
Company
GROMAN INC.
Model
EM-L-N-RB
Catalog number
EM-L-N-RB
Device description
EtchMaster® disposable Large microetching tip prefilled with SYLC (Color code marking PINK) with Regular bend nozzle.
Published
2016-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
10817494020141PackageGS12In Commercial Distribution
20817494020148PackageGS125In Commercial Distribution
30817494020145PackageGS116In Commercial Distribution
00817494020144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081749402014110817494020141
2081749402014820817494020148
3081749402014530817494020145
00817494020144008174940201448174940201440817494020144

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.

Contacts#

Phone, Email table
PhoneEmail
800-906-9298Customerservice@Gromaninc.com

Regulatory Flags#

DUNS number
020124663
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817494020694SafetyNebAM-NEB-FP2023-03-01
00817494020700SafetyO2AM-OXY-FP2023-03-01
10817494020691SafetyNebAM-NEB-FP2023-03-01
10817494020707SafetyO2AM-OXY-FP2023-03-01
20817494020254SafetyFiltaGRO-SF-NEB-25GRO-SF-NEB-252023-01-19
00817494020007EtchmasterEM-L-K-CAEM-L-K-CA2016-09-27
00817494020014EtchmasterEM-L-K-RBEM-L-K-RB2016-09-27
00817494020045EtchmasterEM-L-R-RBEM-L-R-RB2016-09-27
00817494020052EtchmasterEM-S-R-RBEM-S-R-RB2016-09-27
00817494020069EtchmasterEM-S-P-RBEM-S-P-RB2016-09-27
00817494020076EtchmasterEM-S-B-RBEM-S-B-RB2016-09-27
00817494020083EtchmasterEM-L-B-RBEM-L-B-RB2016-09-27
00817494020090EtchmasterEM-S-G-RBEM-S-G-RB2016-09-27
00817494020106EtchmasterEM-L-G-RBEM-L-G-RB2016-09-27
00817494020113EtchmasterEM-S-Y-RBEM-S-Y-RB2016-09-27
00817494020120EtchmasterEM-L-Y-RBEM-L-Y-RB2016-09-27
00817494020137EtchmasterEM-S-J-RBEM-S-J-RB2016-09-27
00817494020151EtchmasterEM-L-F-RBEM-L-F-RB2016-09-27
00817494020168EtchmasterEM-S-O-RBEM-S-O-RB2016-09-27
00817494020175EtchmasterPM-X-L-RBPM-X-L-RB2016-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840479200774ALL SURFACE KITRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-04-03
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00840479201283ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
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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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