FDA.reportPublic FDA data

ISOTEK, MDC Dental

Primary DI
07506338322423
Brand
ISOTEK, MDC Dental
Company
MDC DENTAL
Model
Posterior
Device description
Box with 20 acrylic resin tooth tablets Posterior
Published
2025-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ELKTeeth, Artificial, Backing And Facing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELKTeeth, Artificial, Backing And FacingDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07506338322423PrimaryGS10
17506338322420Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07506338322423075063383224237506338322423
1750633832242017506338322420

GMDN Terms#

Term, Definition table
TermDefinition
Resin artificial teethPrefabricated teeth made of polymer-based material for mounting on dentures. Teeth are normally delivered as sets of front teeth, upper or lower jaw, or sets of premolars and molars, upper or lower jaw, in various sizes, shapes and colours.

Regulatory Flags#

DUNS number
811180298
Device count
20
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07506338322461Nic Tone, MDC Dental Rapid Liquid2025-12-09
07506338301480MDC DentalANTIVET KIT 2023-05-04
07506338322454ROGSON WAX, MDC Dental TRUE EXTRA HARD2025-05-16
07506338322430VIVIDTone 592025-05-12
07506338322447VIVIDTone 652025-05-12
07506338322416ISOTEK, MDC DentalAnterior2025-04-29
17506338322413ISOTEK, MDC DentalAnterior2025-04-29
17506338322420ISOTEK, MDC DentalPosterior2025-04-29
07506338322393Polishine, MDC DentalPOLISHINE 100 g2025-01-29
07506338322386New Flex, MDC Dental20 lb2025-01-17
07506338322379VIVIDTone 652025-01-07
07506338322331Nic Tone, MDC Dental Rapid liquid2024-12-18
07506338322355ROGSON WAX, MDC Dental Self-Adhering Plastic Form2024-12-18
07506338322362VIVIDTone 3.52024-12-18
07506338322232NIC TONE, MDC DentalRapid Liquid2024-08-05
07506338321921ROGSON WAX, MDC Dental ADHESIVE PREFABRICATED PLASTIC FORM2024-04-11
07506338321938ROGSON WAX, MDC Dental ADHESIVE PREFABRICATED PLASTIC FORM2024-04-11
07506338321945ROGSON WAX, MDC Dental ADHESIVE PREFABRICATED PLASTIC FORM2024-04-11
07506338321952ROGSON WAX, MDC Dental ADHESIVE PREFABRICATED PLASTIC FORM2024-04-11
07506338321969ROGSON WAX, MDC Dental ADHESIVE PREFABRICATED PLASTIC FORM2024-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07506338322416ISOTEK, MDC DentalMDC DENTALELK2025-04-29
17506338322413ISOTEK, MDC DentalMDC DENTALELK2025-04-29
17506338322420ISOTEK, MDC DentalMDC DENTALELK2025-04-29
08720604633771Vertex-Dental BVVertex-Dental B.V.ELK2024-04-19
08720604633788Vertex-Dental BVVertex-Dental B.V.ELK2024-04-19
08720604633795Vertex-Dental BVVertex-Dental B.V.ELK2024-04-19
08720604633801Vertex-Dental BVVertex-Dental B.V.ELK2024-04-19
08720604633818Vertex-Dental BVVertex-Dental B.V.ELK2024-04-19
08720604633825Vertex-Dental BVVertex-Dental B.V.ELK2024-04-19
08719425508924Vertex-Dental BVVertex-Dental B.V.ELK2023-08-03
08719425508948Vertex-Dental BVVertex-Dental B.V.ELK2023-08-03
08719425508955Vertex-Dental BVVertex-Dental B.V.ELK2023-08-03
08719425508962Vertex-Dental BVVertex-Dental B.V.ELK2023-08-03
08719425508979Vertex-Dental BVVertex-Dental B.V.ELK2023-08-03
08719425508986Vertex-Dental BVVertex-Dental B.V.ELK2023-08-03
00850039704178OnX Tough - Hollywood BleachSprintray, Inc.ELK2022-10-04
07506338314848Newtek, MDC DentalMDC DENTALELK2022-09-28
07506338314855Newtek, MDC DentalMDC DENTALELK2022-09-28
17506338314845Newtek, MDC DentalMDC DENTALELK2022-09-28
17506338314852Newtek, MDC DentalMDC DENTALELK2022-09-28
00850039704079OnX - BleachSprintray, Inc.ELK2022-02-28
00850039704086OnX - A1Sprintray, Inc.ELK2022-02-28
00850039704093OnX - B1Sprintray, Inc.ELK2022-02-28
08719425508672CeramillVertex-Dental B.V.ELK2019-02-06
08719425508696CeramillVertex-Dental B.V.ELK2019-02-06
08719425508702CeramillVertex-Dental B.V.ELK2019-02-06
08719425508726CeramillVertex-Dental B.V.ELK2019-02-06
08719425508689CeramillVertex-Dental B.V.ELK2019-02-05
08719425508719CeramillVertex-Dental B.V.ELK2019-02-05
08719425508733CeramillVertex-Dental B.V.ELK2019-02-05