FDA.reportPublic FDA data

MDC Dental

Primary DI
07506338300940
Brand
MDC Dental
Company
MDC DENTAL
Model
Bisacryl Nictone BL
Device description
Tone BL. Box wit: 2 10:1 cartridge with 70g (50 ml) + 20 mixing tips + instructions + dispenser gun. It is used in the elaboration of all kinds of temporary dental Provisionals: inlays, onlays, veneers, bridges and partial or total crowns.It can be used as a filling / relining material for precast and temporary composite and metal crowns.
Published
2021-12-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBGCrown And Bridge, Temporary, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K991577000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991577000NIC TONE ACRYLIC RESINSManufacturera Dental Continental1999-09-22EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07506338300940PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07506338300940075063383009407506338300940

GMDN Terms#

Term, Definition table
TermDefinition
Temporary dental crown/bridgeA prosthetic dental device intended to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature23 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
811180298
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07506338322478Nic ToneDark Pink Meharry2026-07-20
07506338322485VIVIDNew Hue2026-07-20
07506338322492VIVIDTone 612026-07-20
07506338322508VIVIDTone 622026-07-20
07506338322515VIVIDTone 662026-07-20
07506338322522VIVIDTone 592026-07-20
07506338322539VIVIDTone 612026-07-20
07506338322546VIVIDTone 622026-07-20
07506338322553VIVIDTone 652026-07-20
07506338322560VIVIDTone 662026-07-20
07506338322577Nic Tone, MDC DentalType PV82026-07-20
07506338322584Nic Tone, MDC DentalType Meharry Dark2026-07-20
07506338322591Nic Tone, MDC DentalType PV12026-07-20
07506338322614Nic Tone, MDC DentalType PV62026-07-20
07506338322638VIVID JELVIVID JEL2026-07-20
07506338322645VIVID JELVIVID JEL2026-07-20
07506338322652VIVID JELVIVID JEL2026-07-20
07506338322669BLU JELBLU JEL2026-07-20
07506338322676BLU JELBLU JEL2026-07-20
07506338322690VIVID JELVIVID JEL2026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07506338322478Nic ToneMDC DENTALEBG2026-07-20
07506338322485VIVIDMDC DENTALEBG2026-07-20
07506338322492VIVIDMDC DENTALEBG2026-07-20
07506338322508VIVIDMDC DENTALEBG2026-07-20
07506338322515VIVIDMDC DENTALEBG2026-07-20
07506338322522VIVIDMDC DENTALEBG2026-07-20
07506338322539VIVIDMDC DENTALEBG2026-07-20
07506338322546VIVIDMDC DENTALEBG2026-07-20
07506338322553VIVIDMDC DENTALEBG2026-07-20
07506338322560VIVIDMDC DENTALEBG2026-07-20
07506338322577Nic Tone, MDC DentalMDC DENTALEBG2026-07-20
07506338322584Nic Tone, MDC DentalMDC DENTALEBG2026-07-20
07506338322591Nic Tone, MDC DentalMDC DENTALEBG2026-07-20
07506338322614Nic Tone, MDC DentalMDC DENTALEBG2026-07-20
07506338322973Nic Tone, MDC DentalMDC DENTALEBG2026-07-20
E235DD16A1ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A2ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A35MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A3MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16B1ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16B1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16B2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16B3MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BL1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BL2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BL3ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BL4MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BLML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09