FDA.reportPublic FDA data

ContacEZ

Primary DI
17310230132168
Brand
ContacEZ
Company
Directa AB
Model
LAB Black Medium
Catalog number
13216
Published
2022-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EHMStrip, Polishing Agent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHMStrip, Polishing AgentDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17310230132168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1731023013216817310230132168

GMDN Terms#

Term, Definition table
TermDefinition
Dental abrasive strip, single-useA manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying the surface of a tooth or restoration during a dental procedure. It is commonly known as a polishing strip. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
353954381
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17310235115869Directa Cheek Retractor Red Adult5115862022-12-07
17310235115876Directa Cheek Retractor Red Child5115872022-12-07
17310235115906Directa Cheek Retractor Ivory Adult5115902022-12-07
17310235115913Directa Cheek Retractor Ivory Child 5115912022-12-07
17310236901089ProphyCare HAp6901082025-09-01
17310231029993ProphyCare HAp6901082025-09-01
17310234160679DryDent Sublingual X-Small4160672022-12-06
17310230021967PrepSure1.0 mm2025-05-27
17310230021974PrepSure1.5 mm2025-05-27
17310230021981PrepSure2.0 mm2025-05-27
17310230924039PrepSure92403924032025-05-27
17310230004045TrollByteLynx Blue #115412450012022-12-06
17310230004052TrollByteLynx Blue #215413150022022-12-06
17310230004069TrollByteLynx Yellow #115434050012022-12-05
17310230004076TrollByteLynx Yellow #215434150022022-12-05
17310236901195ProphyCareMix Single Dose6901192022-12-07
17310230001228TrollBagPSP #1131904032022-12-06
17310230004922TrollByteEzSoft #1155005102022-12-06
17310230004946TrollByteEzSoft #2155005202022-12-06
17310230006674TrollByteEzSoft #2 (Wave)155006202022-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07908738730509DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-13
07908738730516DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-13
07908738730554DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-13
07908738730561DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-13
07908738730578DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-13
07908738730301DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730318DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730325DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730332DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730356DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730363DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730370DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730387DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730394DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730400DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730417DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730424DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730431DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730448DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730455DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730462DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
10190707192270Galaxy™Ortho Organizers, Inc.EHM2025-10-23
10190707192287Galaxy™Ortho Organizers, Inc.EHM2025-10-23
10190707192294Galaxy™Ortho Organizers, Inc.EHM2025-10-23
10190707192300Galaxy™Ortho Organizers, Inc.EHM2025-10-23
10190707192317Galaxy™Ortho Organizers, Inc.EHM2025-10-23
10190707192324Galaxy™Ortho Organizers, Inc.EHM2025-10-23
10190707192331Galaxy™Ortho Organizers, Inc.EHM2025-10-23
10190707192348Galaxy™Ortho Organizers, Inc.EHM2025-10-23
00190707192358Galaxy™Ortho Organizers, Inc.EHM2025-10-23