FDA.reportPublic FDA data

MDC Dental

Primary DI
07506338300223
Brand
MDC Dental
Company
MDC DENTAL
Model
PVS Edge REGULAR BODY
Device description
Light body/normal set.Polyvinylsiloxane elastomer for making dental impressions.
Published
2022-03-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011785000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011785000NOVEL PRINT CYAN ALGINATESManufacturera Dental Continental2001-09-04ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07506338300223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07506338300223075063383002237506338300223

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 Temperature5 Degrees Celsius27 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+523338330333coordrsa@dental.com.mx
3338330333tecnovigilancia@dental.com.mx

Regulatory Flags#

DUNS number
811180298
Device count
1
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
07506338322423ISOTEK, MDC DentalPosterior2025-04-29
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

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