FDA.reportPublic FDA data

Perfectim 90 Second Blue Velvet

Primary DI
10852253006028
Brand
Perfectim 90 Second Blue Velvet
Company
J. MORITA U.S.A., INC
Model
21300550
Device description
PVS Dental Impression Material
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K964692000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K964692000PERFECTIMJ. Morita USA, Inc.1997-02-25ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10852253006028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085225300602810852253006028

GMDN Terms#

Term, Definition table
TermDefinition
Silicone dental impression materialAn elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable 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. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021866033
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08522530060382Free Access II Cheek Retractor Large21303100L2023-06-07
08522530060399Free Access II Cheek Retractor Small21303100S2023-06-07
10852253006240Power Temp Cartridge Kit27410002023-06-07
10852253006257Power Temp Mini Syringe Kit288001002023-06-07
00852253006403Rotary Master Plus1653500002025-05-22
10852253006189Max Bond LC Kit282001002016-09-22
10852253006196Max Bond LC Agent A282002002016-09-22
10852253006202Max Bond LC Agent B282003002016-09-22
00852253006380Free Access II Cheek Retractor Large21303100L2023-07-13
00852253006397Free Access II Cheek Retractor Small21303100S2023-07-13
10852253006127Perfectim Tissue Mimic 213011002016-09-22
10852253006165Silk Line Varnish BaseSilk Line Varnish Base2016-09-22
10852253006172Silk Line Varnish CatalystSilk Line Varnish Catalyst2016-09-22
10852253006233CB Temp A3286002002016-09-22
00852253006274CF Carbon Fiber Post Kit231005502021-10-28
00852253006328GF Glass Fiber Post Kit231005802021-10-28
10852253006226CB Temp A2286001002016-09-22
00852253006090Perfectim Putty Type Kit213000502016-09-22
10852253006011Perfectim 30 Second Blue Velvet213005002016-09-22
10852253006035Perfectim 30 Second SnoWhite213009252016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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18016200021584KROMOPAN SIL light body (2x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
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18016200021607KROMOPAN SIL regular body (2x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021614KROMOPAN SIL regular body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021621KROMOPAN SIL heavy body (2x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021638KROMOPAN SIL heavy body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021676KROMOPAN SIL putty soft (2x300ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021683KROMOPAN SIL putty hard (2x300ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021690KROMOPAN SIL superlight body (2x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021706KROMOPAN SIL superlight body (4x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021713KROMOPAN SIL light body (2x50ml) - FAST SETLASCOD SPAELW2026-05-28
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18016200021737KROMOPAN SIL regular body (2x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021744KROMOPAN SIL regular body (4x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021751KROMOPAN SIL heavy body (2x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021768KROMOPAN SIL heavy body ECONOMY PACK (4x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021805KROMOPAN SIL MONO - monofase (2x50ml)LASCOD SPAELW2026-05-28
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