FDA.reportPublic FDA data

Mavrik Dental System

Primary DI
07290113770027
Brand
Mavrik Dental System
Company
Mavrik Dental System Inc.
Model
3
Catalog number
502-01620
Device description
ArmorLC Syringe
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
EIEDam, Rubber

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIEDam, RubberDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290113770140PackageGS18In Commercial Distribution
07290113770027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290113770140072901137701407290113770140
07290113770027072901137700277290113770027

GMDN Terms#

Term, Definition table
TermDefinition
Gingiva bleaching protectorA non-sterile paste or gel-like substance designed to protect a patient's gums from the hydrogen peroxide (H2O2) found in teeth whitening agents used during chairside light-curing bleaching of the teeth. It is typically supplied in a disposable syringe and is applied with an applicator along the gingiva leaving the teeth exposed for treatment. After application, this device cannot be reused.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117776165
Device count
1
DM 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
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
00840161302694Insti-Dam® - Latex-Free Rubber Dam - 20 CountZIRC DENTAL PRODUCTS, INC.EIE2026-04-07
00840161302717Insti-Dam® - Latex-Free Rubber Dam - Relaxed Fit - 20 CountZIRC DENTAL PRODUCTS, INC.EIE2026-04-07
07630392912129HySolateDent4You AGEIE2025-12-18
07630392912136HySolateDent4You AGEIE2025-12-18
10686864060298HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060304HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060311HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060328HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060335HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060342HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060359HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060366HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060373HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060380HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060397HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060403HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060410HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060427HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060434HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060441HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
07630392910781HySolateDent4You AGEIE2024-07-11
07630392910972HySolateDent4You AGEIE2024-07-11
00630094043265Bioseal Inc.BIOSEALEIE2024-01-18
10732224005581Dental DamsCROSSTEX INTERNATIONAL, INC.EIE2023-12-20
10732224005598Dental DamsCROSSTEX INTERNATIONAL, INC.EIE2023-12-20
10732224005604Dental DamsCROSSTEX INTERNATIONAL, INC.EIE2023-12-20
10732224005611Dental DamsCROSSTEX INTERNATIONAL, INC.EIE2023-12-20
10732224005628Dental DamsCROSSTEX INTERNATIONAL, INC.EIE2023-12-20
10732224005635Dental DamsCROSSTEX INTERNATIONAL, INC.EIE2023-12-20
10732224005642Dental DamsCROSSTEX INTERNATIONAL, INC.EIE2023-12-20