FDA.reportPublic FDA data

Perfectim 30 Second SnoWhite

Primary DI
10852253006035
Brand
Perfectim 30 Second SnoWhite
Company
J. MORITA U.S.A., INC
Model
21300925
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
10852253006035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085225300603510852253006035

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
10852253006028Perfectim 90 Second Blue Velvet213005502016-09-22

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