FDA.reportPublic FDA data

Zekrya Gingival Protector Kit

Primary DI
D033003610961
Brand
Zekrya Gingival Protector Kit
Company
DMG AMERICA, LLC
Model
003-61096
Catalog number
003-61096
Device description
Zekrya Gingival Protector
Published
2022-12-12
Public version status
New
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
BRWProtector, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BRWProtector, DentalAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D033003610961PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Gingival retraction kitA collection of sterile dental instruments and other items used to hold off the gingiva during abutment preparation. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
2018945505gvazquez@dmg-america.com

Regulatory Flags#

DUNS number
106792427
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00325047000005DMG2206002206002025-11-06
D0337884101Kolorz Prophylaxis Paste7884102025-06-04
D0337884111Kolorz Prophylaxis Paste7884112025-06-04
D0337884100Kolorz Prophylaxis Paste7884102025-06-04
D0337884110Kolorz Prophylaxis Paste7884112025-06-04
D0331430200TEMP TABS1430202025-04-18
D0331430330TEMP TABS1430332025-04-18
D033003619011ZenithDental61901003-619012016-09-23
D033003610971Zekrya Small Arc003-61097003-610972022-12-12
D033003610981Zekrya Large Arc003-61098003-610982022-12-12
D0337884011Kolorz Prophylaxis Paste7884017884012022-12-12
D0337884021Kolorz Prophylaxis Paste7884027884022022-12-12
D0337884031Kolorz Prophylaxis Paste7884037884032022-12-12
D0337884041Kolorz Prophylaxis Paste7884047884042022-12-12
D0337884061Kolorz Prophylaxis Paste7884067884062022-12-12
D0337884071Kolorz Prophylaxis Paste7884077884072022-12-12
D0337884081Kolorz Prophylaxis Paste7884087884082022-12-12
D0337884091Kolorz Prophylaxis Paste7884097884092022-12-12
D0337884151Kolorz Prophylaxis Paste7884157884152022-12-12
D0337884161Kolorz Prophylaxis Paste7884167884162022-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250676748188Endoragard teeth protectorSpiggle & Theis Medizintechnik GmbHBRW2026-04-27
08800017902289EZ BITE BLOCK SOFT MOUTH PROP DXM CO., LTDBRW2025-12-18
08800017902296EZ BITE BLOCK SOFT MOUTH PROP DXM CO., LTDBRW2025-12-18
08800017902302EZ BITE BLOCK SOFT MOUTH PROP DXM CO., LTDBRW2025-12-18
08800017902319EZ BITE BLOCK SOFT MOUTH PROP DXM CO., LTDBRW2025-12-18
08800017901817EZ Bite blockDXM CO., LTDBRW2025-12-16
08800017900605EZ Bite blockDXM CO., LTDBRW2025-12-16
00194613123468MSI Precision Specialty InstrumentsMed Saver, Inc.BRW2025-08-01
08800142100949Tera Harz GuardGraphy Inc.BRW2025-07-18
00885797099365RMORmo, Inc.BRW2024-09-02
00885797099372RMORmo, Inc.BRW2024-09-02
00885797099396RMORmo, Inc.BRW2024-09-02
00885797099402RMORmo, Inc.BRW2024-09-02
00885797672278RMORmo, Inc.BRW2024-08-26
00885797672292RMORmo, Inc.BRW2024-08-26
00000008857972RMORmo, Inc.BRW2024-08-12
10889483007563SunMedSUNMED, LLCBRW2024-03-12
08800075604170OSUNG MNDOSUNG MND Co., Ltd.BRW2024-02-19
08800075604187OSUNG MNDOSUNG MND Co., Ltd.BRW2024-02-19
08800075604194OSUNG MNDOSUNG MND Co., Ltd.BRW2024-02-19
00630094199702Bioseal Inc.BIOSEALBRW2023-12-12
10630094199709Bioseal Inc.BIOSEALBRW2023-12-12
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00630094199306Bioseal Inc.BIOSEALBRW2023-12-11
00630094199320Bioseal Inc.BIOSEALBRW2023-12-11
10630094199204Bioseal Inc.BIOSEALBRW2023-12-11
10630094199259Bioseal Inc.BIOSEALBRW2023-12-11
10630094199303Bioseal Inc.BIOSEALBRW2023-12-11
10630094199327Bioseal Inc.BIOSEALBRW2023-12-11