FDA.reportPublic FDA data

Capture

Primary DI
D745701030CAP00040
Brand
Capture
Company
Prismatik Dentalcraft, Inc
Model
70-1030-CAP0004
Catalog number
70-1030-CAP0004
Device description
Soft Putty Catalyst
Published
2017-04-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
D745701030CAP00040PrimaryHIBCC0

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 Temperature4 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9494402629Shelly.Harris@glidewelldental.com

Regulatory Flags#

DUNS number
022761689
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D745701181MIL001610150fastdesign.io70-1181-MIL001670-1181-MIL00162026-03-16
D745701181MIL046710150fastdesign.io70-1181-MIL046770-1181-MIL04672026-03-16
D745701075ZST00760Inclusive® 70-1075-ZST007670-1075-ZST00762026-02-20
D745701161COM00010Inclusive®70-1161-COM000170-1161-COM00012025-12-01
D745701161COM00020Inclusive®70-1161-COM000270-1161-COM00022025-12-01
D745701161COM00040Inclusive®70-1161-COM000470-1161-COM00042025-12-01
D745701161COM00050Inclusive®70-1161-COM000570-1161-COM00052025-12-01
D745701161COM00060Inclusive®70-1161-COM000670-1161-COM00062025-12-01
D745701161COM00080Inclusive®70-1161-COM000870-1161-COM00082025-12-01
D745701161COM00090Inclusive®70-1161-COM000970-1161-COM00092025-12-01
D745701161COM00100Inclusive®70-1161-COM001070-1161-COM00102025-12-01
D745701161COM00120Inclusive®70-1161-COM001270-1161-COM00122025-12-01
D745701161COM00130Inclusive®70-1161-COM001370-1161-COM00132025-12-01
D745701161COM00140Inclusive®70-1161-COM001470-1161-COM00142025-12-01
D745701161COM00160Inclusive®70-1161-COM001670-1161-COM00162025-12-01
D745701161COM00170Inclusive®70-1161-COM001770-1161-COM00172025-12-01
D745701161COM00180Inclusive®70-1161-COM001870-1161-COM00182025-12-01
D745701161COM00200Inclusive®70-1161-COM002070-1161-COM00202025-12-01
D745701161COM00210Inclusive®70-1161-COM002170-1161-COM00212025-12-01
D745701161COM00220Inclusive®70-1161-COM002270-1161-COM00222025-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850078989369SmileSet Impression Kit - RetainerOrtho Dental Lab LLCELW2026-03-20
00850078989376SmileSet Impression Kit - Night GuardOrtho Dental Lab LLCELW2026-03-20
00860014754630Owl Impression KitOWL DENTAL LAB INCELW2026-03-05
E241AA9050Cavex CleverCast - Slow SetCavex Holland B.V.ELW2026-03-05
08719327516010Cavex CleverCast - Normal SetCavex Holland B.V.ELW2026-03-05
E241AA6050Cavex Cream FastCavex Holland B.V.ELW2026-03-04
E241AA6051Cavex Cream Fast Cavex Holland B.V.ELW2026-03-04
07630243601684AdhesiveDent4You AGELW2026-02-10
07630243601691AdhesiveDent4You AGELW2026-02-10
00850079280427CAvexHexa DentalELW2026-01-22
00850079280014One PlusHexa DentalELW2026-01-21
00085007928014One PlusHexa DentalELW2026-01-21
00850057092240HexaHexa DentalELW2026-01-21
00850057092929One PlusHexa DentalELW2026-01-21
00850057092936One PlusHexa DentalELW2026-01-21
00850057092943One PlusHexa DentalELW2026-01-21
00850057092950One PlusHexa DentalELW2026-01-21
00850057092967One PlusHexa DentalELW2026-01-21
00850057092974One PlusHexa DentalELW2026-01-21
00850057092981One PlusHexa DentalELW2026-01-21
00850079280007One PlusHexa DentalELW2026-01-21
00850079280021One PlusHexa DentalELW2026-01-21
00850079280304CavexHexa DentalELW2026-01-21
00850079280311cAVEXHexa DentalELW2026-01-21
00850079280328CavexHexa DentalELW2026-01-21
00850079280335CavexHexa DentalELW2026-01-21
00850079280342CavexHexa DentalELW2026-01-21
00850079280359CavexHexa DentalELW2026-01-21
00850057092714Hexa DentalHexa DentalELW2026-01-19
00850057092721Hexa dentalHexa DentalELW2026-01-19