FDA.reportPublic FDA data

Etchmaster

Primary DI
00817494020175
Brand
Etchmaster
Company
GROMAN INC.
Model
PM-X-L-RB
Catalog number
PM-X-L-RB
Device description
PrepMaster®- Mini disposable Cavity Preparation tip prefilled with 27 micron Aluminum Oxide (Color code marking BROWN) 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
10817494020172PackageGS12In Commercial Distribution
20817494020179PackageGS15In Commercial Distribution
30817494020176PackageGS125In Commercial Distribution
40817494020173PackageGS116In Commercial Distribution
50817494020170PackageGS125In Commercial Distribution
00817494020175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081749402017210817494020172
2081749402017920817494020179
3081749402017630817494020176
4081749402017340817494020173
5081749402017050817494020170
00817494020175008174940201758174940201750817494020175

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
00817494020144EtchmasterEM-L-N-RBEM-L-N-RB2016-09-27
00817494020151EtchmasterEM-L-F-RBEM-L-F-RB2016-09-27
00817494020168EtchmasterEM-S-O-RBEM-S-O-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
00840479201290ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
00840479201306ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
00840479201313ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
00840479202587ETCHMASTERRELIANCE ORTHODONTIC PRODUCTS INCKOJ2026-03-04
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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
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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