FDA.reportPublic FDA data

TEMP TABS

Primary DI
D0331430200
Brand
TEMP TABS
Company
DMG AMERICA, LLC
Model
143020
Device description
FLEXIBLE MATRIX FOR FABRICATING TEMPORARY CROWNS AND BRIDGES AND BITE REGISTRATIONS
Published
2025-04-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EBGCrown And Bridge, Temporary, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033227000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033227000LUXAFORM PLUSDmg USA, Inc.2004-01-16EBG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D0331430200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Composite dental impression materialA thermoplastic material designed to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. It is composed of a mixture of natural resins, fillers, and lubricants. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit145 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
106792427
Device count
1
Lot or batch
true
Expiration date on label
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
D0331430330TEMP TABS1430332025-04-18
D033003619011ZenithDental61901003-619012016-09-23
D033003610961Zekrya Gingival Protector Kit003-61096003-610962022-12-12
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
06942201760748FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201760946FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201760960FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761035FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761134FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761158FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761219FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761226FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761325FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761417FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761424FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761516FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761707FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761714FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761806FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761899FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761998FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201762186FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
07506338322478Nic ToneMDC DENTALEBG2026-07-20
07506338322485VIVIDMDC DENTALEBG2026-07-20
07506338322492VIVIDMDC DENTALEBG2026-07-20
07506338322508VIVIDMDC DENTALEBG2026-07-20
07506338322515VIVIDMDC DENTALEBG2026-07-20
07506338322522VIVIDMDC DENTALEBG2026-07-20
07506338322539VIVIDMDC DENTALEBG2026-07-20
07506338322546VIVIDMDC DENTALEBG2026-07-20
07506338322553VIVIDMDC DENTALEBG2026-07-20
07506338322560VIVIDMDC DENTALEBG2026-07-20
07506338322577Nic Tone, MDC DentalMDC DENTALEBG2026-07-20
07506338322584Nic Tone, MDC DentalMDC DENTALEBG2026-07-20