FDA.reportPublic FDA data

Nic Tone, MDC Dental

Primary DI
07506338322591
Brand
Nic Tone, MDC Dental
Company
MDC DENTAL
Model
Type PV1
Device description
Nic Tone Acrylic PV1 Pour Type 1.1 lb
Published
2026-07-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
07506338322591PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07506338322591075063383225917506338322591

GMDN Terms#

Term, Definition table
TermDefinition
Dental acrylic resinA non-sterile substance intended for professional use as a dental cement, luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, typically for short-term fixed prosthesis use (temporary crowns and bridges used for 6 months or less) or long-term removable prosthesis use. It consists of a self-, light-, or dual-curing acrylic resin material [e.g., polymethylmethacrylate (PMMA)]; it does not include any additional hardening fillers/components. It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Contacts#

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

Regulatory Flags#

DUNS number
811180298
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
07506338322973Nic Tone, MDC DentalType PV22026-07-20

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00810222900206SprintRay Crown HT A1 Single-Unit Capsule - JapanSprintray, Inc.EBG2026-10-09
00810222900213SprintRay Crown HT A2 Single-Unit Capsule - JPSprintray, Inc.EBG2026-10-09
00810222900220SprintRay Crown HT Bleach Single-Unit Capsule - JPSprintray, Inc.EBG2026-10-09
00810222900237SprintRay Crown HT B1 Single-Unit Capsule - JPSprintray, Inc.EBG2026-10-09
00810222900244SprintRay Crown HT B1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBG2026-10-09
00810222900251SprintRay Crown HT Bleach Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBG2026-10-09
00810222900268SprintRay Crown HT A3 Single-Unit Capsule - JPSprintray, Inc.EBG2026-10-09
00810222900275SprintRay Crown HT A3 Single-unit Capsule 3-Pack - JPSprintray, Inc.EBG2026-10-09
00810222900282SprintRay Crown HT Unpigmented Single-Unit Capsule - JPSprintray, Inc.EBG2026-10-09
00810222900299SprintRay Crown HT Unpigmented Single-unit Capsule 3-Pack - JPSprintray, Inc.EBG2026-10-09
00810222900305SprintRay Crown HT A1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBG2026-10-09
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00197998226762Solventum™ Protemp™Solventum Germany GmbHEBG2026-10-08
00197998226779Solventum™ Protemp™Solventum Germany GmbHEBG2026-10-08
00197998226786Solventum™ Protemp™Solventum Germany GmbHEBG2026-10-08
00197998226809Solventum™ Paradigm™Solventum Germany GmbHEBG2026-10-08
00197998226816Solventum™ Paradigm™Solventum Germany GmbHEBG2026-10-08
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06942201762285FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
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