FDA.reportPublic FDA data

MDC Dental

Primary DI
07506338300919
Brand
MDC Dental
Company
MDC DENTAL
Model
Bisacryl Nictone B3
Device description
Tone B3. Box wit: 2 10:1 cartridge with 70g (50 ml) + 20 mixing tips + instructions. 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
07506338300919PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07506338300919075063383009197506338300919

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
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
EPOLPMFLAG5600PMMA CAD/CAM discPOLIDENT d.o.o.EBG2025-05-13
EPOLPMMA1270PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-08
EPOLPMMA1350PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-08
EPOLPMMA1430PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-08
EPOLPMMA0230PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0310PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0390PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0470PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0550PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0630PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0710PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0790PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0870PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0950PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0070PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLPMMA1030PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLPMMA1110PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLPMMA1190PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLKML200160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML200200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML201160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML201200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML202160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML202200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML203160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML203200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML204160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML204200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML205160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML205200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02