FDA.reportPublic FDA data

Perfectim Tissue Mimic

Primary DI
10852253006127
Brand
Perfectim Tissue Mimic
Company
J. MORITA U.S.A., INC
Model
21301100
Device description
PVS Dental Impression Material
Published
2016-09-22
Public version status
Update
Distribution status
Not 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
10852253006127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085225300612710852253006127

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
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
10852253006035Perfectim 30 Second SnoWhite213009252016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08056640080997Ormadent PuttyMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081093OrmactivatorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081109OrmactivatorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081161OrmamaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081185OrmamaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081598Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081604Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081611Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081642Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081666Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081673Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081734Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081741Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081802Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081819Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081826Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081833Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081925Ormalab 85MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081994Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082007Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082014Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082038Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082601Ormalab 85MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082991AlginmajorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083042AlginmajorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083080AlginmaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083134AlginmaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083141AlginmaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083196AlginmaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083202AlginkidMAJOR PRODOTTI DENTARI SPAELW2026-10-20