FDA.reportPublic FDA data

Mavrik Dental System

Primary DI
07290113770010
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
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

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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
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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
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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
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