FDA.reportPublic FDA data

Mavrik Dental System

Primary DI
27290113770120
Brand
Mavrik Dental System
Company
Mavrik Dental System Inc.
Model
1
Catalog number
501-01240
Device description
Whitening Kit
Published
2023-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
27290113770120PackageGS18In Commercial Distribution
07290113770010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2729011377012027290113770120
07290113770010072901137700107290113770010

GMDN Terms#

Term, Definition table
TermDefinition
Teeth whitening kitA collection of devices intended to whiten natural teeth through bleaching. It typically includes a bleaching agent (e.g., a gel containing a low concentration of an oxidizing agent, such as carbamide peroxide or hydrogen peroxide), a syringe(s), a tray(s), a mouthguard, an applicator (e.g., a brush) and strips to apply/retain the bleaching agent to/on the teeth for a recommended period. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+972549211030aner.heller@mavrikdental.com

Regulatory Flags#

DUNS number
117776165
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
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
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
07290113770157Mavrik Dental System01501-014202023-11-01

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