FDA.reportPublic FDA data

ARTICULATING PAPER HORSESHOE, BLUE/RED, THIN

Primary DI
07640159161745
Brand
ARTICULATING PAPER HORSESHOE, BLUE/RED, THIN
Company
Produits dentaires S.A.
Model
36415
Device description
Articulating Papers are occlusal marking papers, whose aim is to highlight occlusion contacts, by creating a mark on the corresponding teeth surfaces (ink transfer). The products are used in the dentistry field. Pack of 6x12 sheets
Published
2022-06-28
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
07640159161745PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640159161745076401591617457640159161745

GMDN Terms#

Term, Definition table
TermDefinition
Dental articulation paperA strip or sheet of suitable material coated with pigment and used for marking areas of contact between opposite teeth, restorations or appliances. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
480420090
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
07640159163350Drill-A-Post - N°1225112023-05-24
07640159163367Drill-A-Post - N°2225122023-05-24
07640159163374Drill-A-Post - N°3225132023-05-24
07640159163381Drill-A-Post - N°4225142023-05-24
07640159163398Drill-A-Post - N°1 - Rack of 6 pieces225012023-05-24
07640159163404Drill-A-Post - N°2 - Rack of 6 pieces225022023-05-24
07640159163411Drill-A-Post - N°3 - Rack of 6 pieces225032023-05-24
07640159163428Drill-A-Post - N°4 - Rack of 6 pieces225042023-05-24
07640159161530DS TULSA Generic needle (5)21412DSIN30G52022-06-30
07640159161912TOFFLEMIRE MATRIX BANDS X-THIN N.1415112022-06-29
07640159161929TOFFLEMIRE MATRIX BANDS X-THIN N.2415122022-06-29
07640159161936TOFFLEMIRE MATRIX BANDS X-THIN N.3415132022-06-29
07640159161943TOFFLEMIRE MATRIX BANDS X-THIN N.11415142022-06-29
07640159161950TOFFLEMIRE MATRIX BANDS X-THIN N.13415152022-06-29
07640159161967TOFFLEMIRE MATRIX BANDS X-THIN N.14415162022-06-29
07640159161974TOFFLEMIRE MATRIX BANDS X-THIN N.15415172022-06-29
07640159161981TOFFLEMIRE MATRIX BANDS X-THIN ASSTD415182022-06-29
07640159161998TOFFLEMIRE MATRIX BANDS THIN N°1415212022-06-29
07640159162001TOFFLEMIRE MATRIX BANDS THIN N°2415222022-06-29
07640159162018TOFFLEMIRE MATRIX BANDS THIN N°3415232022-06-29

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
17310230000757TrollFoilDirecta ABEFH2022-12-06
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