FDA.reportPublic FDA data

FIBRAPOST LUX N° 1

Primary DI
07640159162834
Brand
FIBRAPOST LUX N° 1
Company
Produits dentaires S.A.
Model
22590
Device description
Glass fibre posts - Core build up - Rack of 12 -Total Length 19mmLength of tapered part 11mmDiameter of the lower tip 0.85mmDiameter of the cylindrical part 1.30
Published
2022-06-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELRPost, Root Canal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELRPost, Root CanalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640159162834PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640159162834076401591628347640159162834

GMDN Terms#

Term, Definition table
TermDefinition
Root canal post, preformedA prefabricated endodontic rod designed for insertion into the root canal of a patient to support and retain a crown prosthesis. It is typically a solid, cylindrical, metal (e.g., stainless steel, gold alloy) piece with a proximal end appropriate to support the crown on top; it is, however, available in a variety of shapes, dimensions, and materials (e.g., ceramics, fibre-reinforced polymers). In addition, it is available in a variety of types (e.g., non-threaded, pre-threaded, or self-tapping; straight or tapered). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+41219212631info@pd-dental.com

Regulatory Flags#

DUNS number
480420090
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
07640159162711ROSEN ROOT-CANAL CEMENT102452022-06-15
07640159162728Eugenol - 15ml114202022-06-15
07640159162735Eugenol - 30 ml114212022-06-15
07640159162742Eugenol - 100 ml114222022-06-15
07640159162759ZINC OXIDE - 500g114302022-06-15
07640159162766ZINC OXIDE - 100g114312022-06-15
07640159162773ZINC OXIDE - 250g114322022-06-15
07640159162780ZINC OXIDE - 1'000g114332022-06-15
07640159162704EssenSeal10246EssenSeal2022-06-13
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
07640159160076HOOKED NEEDLE N. 1 RED202642022-06-21
07640159160083HOOKED NEEDLE N. 2 BLUE202652022-06-21
07640159160359CLASSIC NEEDLE N. 0 YELLOW202202022-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08059388441167Prosthetic Over Post # 0OVERFIBERS SRLELR2025-03-12
08059388441174Prosthetic Over Post # 1OVERFIBERS SRLELR2025-03-12
08059388441181Prosthetic Over Post # 2OVERFIBERS SRLELR2025-03-12
08059388441198Prosthetic Over Post # 3OVERFIBERS SRLELR2025-03-12
08059388441204Prosthetic Over Post # 4OVERFIBERS SRLELR2025-03-12
08059388441211Over Post+ # 0OVERFIBERS SRLELR2025-03-12
08059388441228Over Post+ # 1OVERFIBERS SRLELR2025-03-12
08059388441235Over Post+ # 2OVERFIBERS SRLELR2025-03-12
08059388441242Over Post+ # 3OVERFIBERS SRLELR2025-03-12
08059388441259Over Post+ # 4OVERFIBERS SRLELR2025-03-12
08059388441365Endodontic Over Post # 0OVERFIBERS SRLELR2025-03-12
08059388441372Endodontic Over Post # 1OVERFIBERS SRLELR2025-03-12
08059388441389Endodontic Over Post # 2OVERFIBERS SRLELR2025-03-12
08059388441396Endodontic Over Post # 3OVERFIBERS SRLELR2025-03-12
08059388441402Endodontic Over Post # 4OVERFIBERS SRLELR2025-03-12
08059388441518Duo Over Post # 1OVERFIBERS SRLELR2025-03-12
08059388441525Duo Over Post # 2OVERFIBERS SRLELR2025-03-12
08059388441556Polygon Over Post # 1OVERFIBERS SRLELR2025-03-12
08059388441563Polygon Over Post # 2OVERFIBERS SRLELR2025-03-12
08059388441570Polygon Over Post # 3OVERFIBERS SRLELR2025-03-12
08059388441617Hi-Rem Prosthetic Post # 0OVERFIBERS SRLELR2025-03-12
08059388441624Hi-Rem Prosthetic Post # 1OVERFIBERS SRLELR2025-03-12
08059388441631Hi-Rem Prosthetic Post # 2OVERFIBERS SRLELR2025-03-12
08059388441648Hi-Rem Prosthetic Post # 3OVERFIBERS SRLELR2025-03-12
08059388441655Hi-Rem+ # 0OVERFIBERS SRLELR2025-03-12
08059388441662Hi-Rem+ # 1OVERFIBERS SRLELR2025-03-12
08059388441679Hi-Rem+ # 2OVERFIBERS SRLELR2025-03-12
08059388441686Hi-Rem+ # 3OVERFIBERS SRLELR2025-03-12
08059388441778Hi-Rem Endodontic Post # 1OVERFIBERS SRLELR2025-03-12
08059388441785Hi-Rem Endodontic Post # 2OVERFIBERS SRLELR2025-03-12