FDA.reportPublic FDA data

PERFECTO

Primary DI
00818524020042
Brand
PERFECTO
Company
CROWN DELTA CORPORATION
Model
DW07
Catalog number
DW07
Device description
PERFECTO VINYL PUTTY REGULAR SET (A & B) KIT
Published
2018-02-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818524020042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818524020042008185240200428185240200420818524020042

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit73 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
030479000
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818524020721PerectoDW642026-04-22
00818524020714EVOLVE KoR10-1015A10-1015A2023-09-21
00818524020370IMPRESS-RITE T-MIXING TIPSIMP-8104TIMP-8104T2019-10-29
00818524020417IMPRESS-RITE T-MIXING TIPSIMP-8105TIMP-8105T2019-10-29
00818524020455IMPRESS-RITE T-MIXING TIPSIMP-8106TIMP-8106T2019-10-29
00818524020547IMPRESS-RITE HP MIXING TIPSVPS-8120VPS-81202019-10-07
00818524020608IMPRESS-RITE T-MIXING TIPSVPS-8108TVPS-8108T2020-02-04
00818524020660IMPRESS-RITE T-MIXING TIPSVPS8150TVPS8150T2020-12-14
00818524020691IMPRESS-RITE HP-MIXING TIPSIMP-8140IMP-81402020-12-22
00818524020080ROOT LABS - TIPSRL500RL5002017-05-01
00818524020097ROOT LABS - MIXING TIPSRL510RL5102017-05-01
00818524020158ROOT LABS - MIXING TIPSRL850RL8502017-05-01
00818524020165ROOT LABS - DISPENSERRL762RL7622017-05-01
00818524020479IMPRESS-RITE HP MIXING TIPSVPS-8105VPS-81052017-07-05
00818524020486IMPRESS-RITE HP MIXING TIPSVPS-8106VPS-81062017-07-05
00818524020493IMPRESS-RITE HP MIXING TIPSVPS-8104VPS-81042017-07-05
00818524020509IMPRESS-RITE INTRA-ORAL TIPSVPS-8103VPS-81032017-07-05
00818524020516IMPRESS-RITE INTRA-ORAL TIPSVPS-8101VPS-81012017-07-05
00818524020561IMPRESS-RITE DISPENSERVPS-8201VPS-82012017-07-05
00818524020639IMPRESS-RITEIMP-8140IMP-81402017-07-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18016200021546KROMOPAN SIL putty soft (2x300ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021553KROMOPAN SIL putty hard (2x300ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021560KROMOPAN SIL superlight body (2x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021577KROMOPAN SIL superlight body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021584KROMOPAN SIL light body (2x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021591KROMOPAN SIL light body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
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
18016200021720KROMOPAN SIL light body ECONOMY PACK (4x50ml) - FAST SETLASCOD SPAELW2026-05-28
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
18016200021843KromopanSil Bite 2x50mlLASCOD SPAELW2026-05-28
18016200010298IQ - alginato non cromatico verde tipo 1 (24x450g)LASCOD SPAELW2026-05-27
18016200010496IQ TROPICAL - alginato cromatico tipo 1 (24x450g)LASCOD SPAELW2026-05-27
18016200010748IQ - alginato chrom viola/lilla/verde tipo 1 (24x450g)LASCOD SPAELW2026-05-27
18016200011318Mono7LASCOD SPAELW2026-05-27
07640181478934AFFINISColtène/Whaledent AGELW2022-03-27
07640181478958AFFINISColtène/Whaledent AGELW2022-03-27
07640181478972AFFINISColtène/Whaledent AGELW2022-03-27
07640181479030AFFINISColtène/Whaledent AGELW2022-03-27