FDA.reportPublic FDA data

Mavrik Dental System

Primary DI
07290113770157
Brand
Mavrik Dental System
Company
Mavrik Dental System Inc.
Model
01
Catalog number
501-01420
Device description
Whitening MPU S
Published
2023-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EEGHeat Source For Bleaching Teeth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EEGHeat Source For Bleaching TeethDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290113770157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290113770157072901137701577290113770157

GMDN Terms#

Term, Definition table
TermDefinition
Teeth whitening trayA custom-made device intended to retain a bleaching agent for whitening natural teeth through bleaching. It is made of polymer materials in the form of a mould to fit precisely over the teeth for a specified patient. This is a single-patient reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117776165
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290113770010Mavrik Dental System1501-012402023-11-01
07290113770034Mavrik Dental System1502-017102023-11-01
07290113770065Mavrik Dental System1502-018102023-11-01
07290113770072Mavrik Dental System1502-018202023-11-01
07290113770089Mavrik Dental System1502-018122023-11-01
07290113770096Mavrik Dental System1502-018222023-11-01
07290113770003Mavrik Dental System1501-011-002023-11-01
27290113770120Mavrik Dental System1501-012402023-11-01
07290113770027Mavrik Dental System3502-016202023-11-01
07290113770171Mavrik Dental System1502-017102023-11-01
07290113770041Mavrik Dental System8502-014132023-11-01
07290113770058Mavrik Dental System13502-014102023-11-01
07290113770249Mavrik Dental System1502-018102023-11-01
07290113770256Mavrik Dental System1502-018202023-11-01
07290113770263Mavrik Dental System1502-018122023-11-01
07290113770270Mavrik Dental System1502-018222023-11-01
07290113770102Mavrik Dental System01501-018422023-11-01
07290113770119Mavrik Dental System01501-018402023-11-01
07290113770126Mavrik Dental System01501-018522023-11-01
07290113770133Mavrik Dental System01501-018502023-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00872320006440Picasso Pro Diode LaserCAO GROUP, INC.EEG2026-04-10
E241WR0040WR Premium Perfection Kit + LedCavex Holland B.V.EEG2026-03-09
08719327516041WR Premium Perfection Kit + LedCavex Holland B.V.EEG2026-03-09
E241WR0100WR Premium Perfection Kit Led EUCavex Holland B.V.EEG2026-03-09
E241BW0620Cavex Bite&White ExSense BrushpenCavex Holland B.V.EEG2026-03-05
E241BW1600Cavex Bite&White ExSense tubeCavex Holland B.V.EEG2026-03-05
E241BW0070Cavex Bite&White 3 syringes CP16Cavex Holland B.V.EEG2026-03-05
E241BW0080Cavex Bite&White 3 syringes CP22Cavex Holland B.V.EEG2026-03-05
E241BW0310Cavex Bite&White Ready 2 UseCavex Holland B.V.EEG2026-03-05
E241BW0500Cavex Bite&White In-Office 25% Starter Cavex Holland B.V.EEG2026-03-05
E241BW0510Cavex Bite&White In-Office 25% Pen bulkCavex Holland B.V.EEG2026-03-05
E241BW0520Cavex Bite&White In-Office 25% Barrier bulkCavex Holland B.V.EEG2026-03-05
08719327516058Cavex Bite&White ExSense BrushpenCavex Holland B.V.EEG2026-03-05
E241BW0820Cavex Bite&White Aligner Whitening penCavex Holland B.V.EEG2026-03-05
08720299509207Cavex Bite&White ExSense tubeCavex Holland B.V.EEG2026-03-05
00850079280397CavexHexa DentalEEG2026-01-22
00850079280403CavexHexa DentalEEG2026-01-22
00850079280410CavexHexa DentalEEG2026-01-22
00850079280137HEXAHexa DentalEEG2026-01-21
00850079280144HexaHexa DentalEEG2026-01-21
00301260033211Colgate Optic White Professional In Office Whitening KitCOLGATE ORAL PHARMACEUTICALS, INC.EEG2025-11-06
00860012825516SmileDirectClub Whitening Pen - 9 Pack Plus LightOrtho Dental Lab LLCEEG2025-10-16
00860012825530SmileDirectClub Whitening Pen - 4 Pack Plus LightOrtho Dental Lab LLCEEG2025-10-16
00850078989123SmileSet Premium Whitening Kit – BlackOrtho Dental Lab LLCEEG2025-09-25
00850078989130SmileSet Premium Whitening Kit – MintOrtho Dental Lab LLCEEG2025-09-25
00850078989147SmileSet Premium Whitening Kit – WhiteOrtho Dental Lab LLCEEG2025-09-25
06974624062116PIOONWuhan Pioon Technology Co., Ltd.EEG2025-07-08
06974624062109PIOONWuhan Pioon Technology Co., Ltd.EEG2025-07-07
06972868590013AHVTEFOSHAN OUSIDUN PERSONAL CARE PRODUCTS CO.,LTDEEG2025-05-06
06972868590020AHVTEFOSHAN OUSIDUN PERSONAL CARE PRODUCTS CO.,LTDEEG2025-05-06