FDA.reportPublic FDA data

Nic Tone, MDC Dental

Primary DI
07506338300353
Brand
Nic Tone, MDC Dental
Company
MDC DENTAL
Model
Bisacryl
Device description
Acrylic Temporary Resin for dental use, Tone A1. Content: 1 Cartridge, with 76 g + 10 mixing tips.
Published
2021-07-26
Public version status
Update
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
07506338300353PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07506338300353075063383003537506338300353

GMDN Terms#

Term, Definition table
TermDefinition
Dental crown/bridge, temporaryA prosthetic dental device used 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
+523338330333tecnovigilancia@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
06942480706086FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-21
06942480707618FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-21
06942480707632FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-21
06942480707649FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-21
06942480707724FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-21
06942480707809FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-21
06942480707823FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-21
06942480707830FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-21
06942201776305FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788100FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788292FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788391FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788483FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788582FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788773FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788780FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788797FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788971FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789060FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789152FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789169FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789183FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789251FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789350FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789442FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789459FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789541FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789732FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201790028FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942480707625FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17