FDA.report

Template® Ultra Quick Matrix Material 4pk

Primary DI
07540172000574
Brand
Template® Ultra Quick Matrix Material 4pk
Company
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
Model
028904
Catalog number
028904
Device description
Ultra Quick Matrix Material
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

Product Code Classifications

CodeDeviceSpecialtyClass
EIDSyringe, Restorative And Impression MaterialDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07540172000574PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07540172000574075401720005747540172000574

GMDN Terms

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.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Total Volume50Milliliter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Min Relative Humidity
Storage Environment Temperature15 Degrees Celsius28 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit82 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)265-3444info@clinicianschoice.com

Regulatory Flags

DUNS number
626406016
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
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 DIBrandModelCatalogPublished
07540172019125G5 All-Purpose Desensitizer2261052261052024-09-23
07540172019132G5 All-Purpose Desensitizer2261102261102024-09-23
07540172019514Evanesce™ Nano-Enhanced Universal Restorative A2U Single Dose Sample9732129732122024-09-17
07540172019644Evanesce™ Silk Nano-Enhanced Universal Restorative A1E Single Dose3235703235702024-09-17
07540172019651Evanesce™ Silk Nano-Enhanced Universal Restorative A2E Single Dose3235713235712024-09-17
07540172019668Evanesce™ Silk Nano-Enhanced Universal Restorative A3E Single Dose3235723235722024-09-17
07540172019675Evanesce™ Silk Nano-Enhanced Universal Restorative B1E Single Dose3235733235732024-09-17
07540172019682Evanesce™ Silk Nano-Enhanced Universal Restorative A2D Single Dose3235743235742024-09-17
07540172019699Evanesce™ Silk Nano-Enhanced Universal Restorative A3D Single Dose3235753235752024-09-17
07540172019705Evanesce™ Silk Nano-Enhanced Universal Restorative B2U Single Dose3235763235762024-09-17
07540172019712Evanesce™ Silk Nano-Enhanced Universal Restorative C2U Single Dose3235773235772024-09-17
07540172019729Evanesce™ Silk Nano-Enhanced Universal Restorative A2U Single Dose Sample9732119732112024-09-17
07540172019507MPa Universal™ Light-Cure Universal Adhesive Unit Dose Sample9732669732662024-08-09
07540172019392EdgeDam™ Refill Heavy 6x6 Latex-FreeEDVLFH6650EDVLFH66502024-06-04
07540172019408EdgeDam™ Refill Heavy 5x5 Latex-FreeEDVLFH5550EDVLFH55502024-06-04
07540172019415EdgeDam™ Refill Medium 6x6 Latex-FreeEDVLFM6650EDVLFM66502024-06-04
07540172019422EdgeDam™ Refill Medium 5x5 Latex-FreeEDVLFM5550EDVLFM55502024-06-04
07540172019439EdgeDam™ Refill Heavy 6x6 LatexEDBLH6636EDBLH66362024-06-04
07540172019446EdgeDam™ Refill Heavy 5x5 LatexEDBLH5552EDBLH55522024-06-04
07540172019453EdgeDam™ Refill Medium 6x6 LatexEDBLM6636EDBLM66362024-06-04

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840481135309MICROPRIMEZest Anchors, LLCEID2026-03-10
00840479201115CR MARK II SYRINGERELIANCE ORTHODONTIC PRODUCTS INCEID2026-02-27
00304040194782Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
00304040194799Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
00304040194805Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
00371347019889Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2025-12-30
00841336104877Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEID2025-12-22
00841336104891Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEID2025-12-22
00841336104907Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEID2025-12-22
00841336104914Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEID2025-12-22
00810126504357Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEID2025-12-16
00810126504388Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEID2025-12-16
00371347017786Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2025-11-18
08800017902265DX-MixerDXM CO., LTDEID2025-09-29
20840326424302DefendYoung Innovations, Inc.EID2025-09-05
00883205032041ExperTempULTRADENT PRODUCTS, INC.EID2025-08-23
E217172261Mixing TipsKettenbach GmbH & Co. KGEID2025-08-14
E239D49701X41Mixing tipsDreve Dentamid GmbHEID2025-08-13
00195062154119Kerr RestorativesKerr CorporationEID2025-08-08
00195062154126Kerr RestorativesKerr CorporationEID2025-08-08
00195062154133Kerr RestorativesKerr CorporationEID2025-08-08
00195062154140Kerr RestorativesKerr CorporationEID2025-08-08
00195062154157Kerr RestorativesKerr CorporationEID2025-08-08
00195062154164Kerr RestorativesKerr CorporationEID2025-08-08
E239D496041TipsDreve Dentamid GmbHEID2025-07-21
E239D49701X61Mixing tipsDreve Dentamid GmbHEID2025-07-18
00359883007201EVANESCEDEN-MAT HOLDINGS, LLCEID2025-05-30
00813909013350Dental Cartridge DispenserNOVABONE PRODUCTS, LLCEID2025-04-25
E217150221Application TipsKettenbach GmbH & Co. KGEID2025-04-03
E217150231Application TipsKettenbach GmbH & Co. KGEID2025-04-03