FDA.reportPublic FDA data

TrollFoil

Primary DI
17310230000757
Brand
TrollFoil
Company
Directa AB
Model
Blue
Catalog number
12000101
Published
2022-12-06
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

Product Codes#

Code, Name table
CodeName
EFHPaper, Articulation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFHPaper, ArticulationDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17310230000757PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1731023000075717310230000757

GMDN Terms#

Term, Definition table
TermDefinition
Dental articulatorA hinged, mechanical, dental device designed to simulate the movement of a patient's upper and lower jaws and onto which maxillary and mandibular casts or models are attached according to a pre-recorded intermaxillary relationship. It is designed to simulate all or part of the mandibular movements and is used for, e.g., examination, diagnosis, or to construct dental appliances. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
353954381
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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
17310231029993ProphyCare HAp6901082025-09-01
17310230021639LuxatorLK7506331U2025-02-19
17310230021646LuxatorLK VET506332U2025-02-19
17310230021196TrollBagCamera Sleeve 306, 500 pcs132003062022-12-09
17310230021202Camera SleeveTrollBag XL, 300 pcs132003002022-12-09
17310230400304Ceramir Crown & Bridge QuikCap102572024-03-28
17310230102772Ceramir Crown & Bridge QuikMix102772024-03-28
17310230102789Ceramir Crown & Bridge QuikMix102782024-03-28
17310230400373Ceramir BIC QuikCap102912024-03-28
17310230400328Ceramir Crown & Bridge QuikMix400322024-03-28
17310230021318LuxatorLK4506330U2022-12-07
17310230021325LuxatorLK7506331U2022-12-07
17310230021332LuxatorLK VET506332U2022-12-07
17310230021424LuxatorSK4506333U2022-12-07
17310230021622LuxatorP Kit506635U2022-12-07
17310230021585LuxatorP1506631U2022-12-07
17310230021592LuxatorP2506632U2022-12-07
17310230021608LuxatorP3506633U2022-12-07
17310230021615LuxatorP4506634U2022-12-07
17310230021493LuxatorL2S TiN506434U2022-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08906110440175Maarc dental - Articulating PaperSHIVA PRODUCTSEFH2024-10-02
10889813062088Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062095Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062101Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062125Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062132Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062149Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062156Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062163Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
00889813062173Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
D956OCCLUFL0DSI Occlufoil 6mmD.S.I DENTAL SOLUTIONS LTDEFH2024-07-01
D040600081ARDENT WHIP-MIX CORPORATIONEFH2023-10-27
D040600130ARDENT WHIP-MIX CORPORATIONEFH2023-10-27
D040602061ARDENT WHIP-MIX CORPORATIONEFH2023-10-27
D040600021ARDENT DISPOSABLE DENTWHIP-MIX CORPORATIONEFH2023-08-18
D040600031ARDENT DISPOSABLE DENTWHIP-MIX CORPORATIONEFH2023-08-18
00371347008197Advance Dental ProductsThe Atlanta Dental Supply CompanyEFH2023-05-11
00371347008210Advance Dental ProductsThe Atlanta Dental Supply CompanyEFH2023-05-11
00371347008234Advance Dental ProductsThe Atlanta Dental Supply CompanyEFH2023-05-11
00371347008258Advance Dental ProductsThe Atlanta Dental Supply CompanyEFH2023-05-11
17310230000771TrollFoilDirecta ABEFH2022-12-06
17310230000788TrollFoilDirecta ABEFH2022-12-06
17310230000795TrollFoilDirecta ABEFH2022-12-06
17310230000801TrollFoilDirecta ABEFH2022-12-06
17310230005226TrollFoilDirecta ABEFH2022-12-06
D773140HT102B0Health-Tec/DHP Articulating PaperDental Health Products IncEFH2022-11-09
D773140HT103B0Health-Tec/DHP Articulating PaperDental Health Products IncEFH2022-11-09
D773140HT104RB0Health-Tec/DHP Articulating PaperDental Health Products IncEFH2022-11-09
D773140HT105RB0Health-Tec/DHP Articulating PaperDental Health Products IncEFH2022-11-09
07898488906975ORTHOMETRIC ACETATE TRACING PAPERORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEFH2022-11-08