FDA.reportPublic FDA data

MDC Dental

Primary DI
07506338300735
Brand
MDC Dental
Company
MDC DENTAL
Model
BIsacryl Nictone A1 Tone
Device description
Tone A1. 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
2021-09-10
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
07506338300735PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07506338300735075063383007357506338300735

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

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
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06942201774288FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774387FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774479FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774578FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774769FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774950FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774967FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774981FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775056FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775155FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775179FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775230FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775247FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
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06942201775346FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775438FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775537FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775728FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201760748FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201760946FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201760960FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761035FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761134FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761158FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761219FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761226FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761325FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28