FDA.reportPublic FDA data

START VPS

Primary DI
00816594021372
Brand
START VPS
Company
DANVILLE MATERIALS, LLC
Model
80016
Catalog number
80016
Device description
START VPS,PUTTY KIT
Published
2016-06-22
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
00816594021372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816594021372008165940213728165940213720816594021372

GMDN Terms#

Term, Definition table
TermDefinition
Polyether dental impression materialAn elastomeric, polyether-based material capable of reacting to form a rubber-like substance used 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 Temperature074 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(760)743-7744xxx@xxx.xxx

Regulatory Flags#

DUNS number
601302743
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
true
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
00816594020122ACCOLADE90546905462016-06-22
00816594020238ACCOLADE90551905512016-06-22
00816594021600MICROPRIME87001870012016-06-22
00816594021617MICROPRIME94263942632016-06-22
00816594020092ACCOLADE OP93598935982016-06-22
00816594020108ACCOLADE90552905522016-06-22
00816594020115ACCOLADE90553905532016-06-22
00816594020139ACCOLADE90547905472016-06-22
00816594020146ACCOLADE90548905482016-06-22
00816594020153ACCOLADE90549905492016-06-22
00816594020160ACCOLADE90840908402016-06-22
00816594020177ACCOLADE90554905542016-06-22
00816594020184ACCOLADE90550905502016-06-22
00816594020191ACCOLADE90555905552016-06-22
00816594020207ACCOLADE90556905562016-06-22
00816594020214ACCOLADE90557905572016-06-22
00816594020221ACCOLADE90558905582016-06-22
00816594020245ACCOLADE OP93597935972016-06-22
00816594020252ACCOLADE PV91231912312016-06-22
00816594020269ACCOLADE PV90559905592016-06-22

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