FDA.reportPublic FDA data

Qartz

Primary DI
00353045001168
Brand
Qartz
Company
DHARMA RESEARCH, INC.
Model
58-00208
Catalog number
58-00208
Device description
Qartz Prophylaxis Paste Mint Medium Grit x 200 Unit-dose Cups
Published
2026-10-13
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJRAgent, Polishing, Abrasive, Oral Cavity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJRAgent, Polishing, Abrasive, Oral CavityDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10353045001165PackageGS112In Commercial Distribution
00353045001168PrimaryGS10
00353045004534Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035304500116510353045001165
00353045001168003530450011683530450011680353045001168
00353045004534003530450045343530450045340353045004534

GMDN Terms#

Term, Definition table
TermDefinition
Professional dental abrasive materialA dental material made from various base substances having some abrasive qualities [e.g., treated sodium bicarbonate (NaHCO3) or aluminium oxide (Al2O3)] and applied by a healthcare professional with an appropriate device (e.g., a dental abrasive air jet system) to the surface of teeth or dental devices (e.g., restorations). It has a wide variety of both prophylactic and treatment applications such as the removal of plaque and stains, cleaning fissures (above and below the gingiva), the preparation of a tooth surface prior to bonding, cleaning orthodontic appliances (bands and brackets), removing adhesive residue, and cleaning implants prior to loading. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
3054829669rcarles@dharmaresearch.com
8778333725info@dharmaresearch.com

Regulatory Flags#

DUNS number
078444642
Device count
200
DM exempt
true
Premarket exempt
true
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
00353045000550Qartz58-0003158-000312026-10-13
00353045000567Qartz58-0003258-000322026-10-13
00353045000598Qartz58-0005158-000512026-10-13
00353045000932Qartz58-0005258-000522026-10-13
00353045000949Qartz58-0005758-000572026-10-13
00353045003773Qartz58-0013258-001322026-10-13
00353045003780Qartz58-0013158-001312026-10-13
00353045003797Qartz58-0013058-001302026-10-13
00353045000529Qartz58-0002858-000282026-10-12
00353045000536Qartz58-0002958-000292026-10-12
00353045000543Qartz58-0003058-000302026-10-12
00353045000581Qartz58-0005058-000502026-10-12
00353045000604Qartz58-0005558-000552026-10-12
00353045000611Qartz58-0005658-000562026-10-12
00353045000512Qartz58-0002758-000272026-10-09
00353045000628Jade20-0000520-000052016-10-07
00353045000635Jade20-0000220-000022016-10-07
00353045000642Jade20-0000320-000032016-10-07
00353045000659Jade20-0000420-000042016-10-07
00353045000666Jade20-0000120-000012016-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00353045000550QartzDHARMA RESEARCH, INC.EJR2026-10-13
00353045000567QartzDHARMA RESEARCH, INC.EJR2026-10-13
00353045000598QartzDHARMA RESEARCH, INC.EJR2026-10-13
00353045000932QartzDHARMA RESEARCH, INC.EJR2026-10-13
00353045000949QartzDHARMA RESEARCH, INC.EJR2026-10-13
00353045003773QartzDHARMA RESEARCH, INC.EJR2026-10-13
00353045003780QartzDHARMA RESEARCH, INC.EJR2026-10-13
00353045003797QartzDHARMA RESEARCH, INC.EJR2026-10-13
00353045000529QartzDHARMA RESEARCH, INC.EJR2026-10-12
00353045000536QartzDHARMA RESEARCH, INC.EJR2026-10-12
00353045000543QartzDHARMA RESEARCH, INC.EJR2026-10-12
00353045000581QartzDHARMA RESEARCH, INC.EJR2026-10-12
00353045000604QartzDHARMA RESEARCH, INC.EJR2026-10-12
00353045000611QartzDHARMA RESEARCH, INC.EJR2026-10-12
00353045000512QartzDHARMA RESEARCH, INC.EJR2026-10-09
07613353171582AIR-FLOW-PIEZONE.M.S. Electro Medical Systems S.A.EJR2026-07-13
00810184450146RodinPac-Dent, Inc.EJR2026-06-10
E217149401ProphyProtectKettenbach GmbH & Co. KGEJR2026-06-08
EMICESA01Ena ShinyMICERIUM SPAEJR2025-11-07
EMICESB01Ena ShinyMICERIUM SPAEJR2025-11-07
00190707191177Ortho Technology®Ortho Organizers, Inc.EJR2025-10-23
17310236901089ProphyCare HApDirecta ABEJR2025-09-01
10304040192778Henry ScheinHENRY SCHEIN, INC.EJR2025-07-02
07615208479195VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479201VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479218VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479225VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479232VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479249VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479379VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12