FDA.reportPublic FDA data

FIBRAPOST LUX N°1-4

Primary DI
07640159162872
Brand
FIBRAPOST LUX N°1-4
Company
Produits dentaires S.A.
Model
22594
Device description
Glass fibre posts - Core build up - Rack of 12 - 3 of each size - N°1 Total Length 19mm Length of tapered part 11mm Diameter of the lower tip 0.85mm Diameter of the cylindrical part 1.30mm N°2 Total Length 19mm Length of tapered part 11mm Diameter of the lower tip 1.06mm Diameter of the cylindrical part 1.50mm N°3 Total Length 19mm Length of tapered part 11mm Diameter of the lower tip 1.26mm Diameter of the cylindrical part 1.70mm N°4 Total Length 19mm Length of tapered part 11mm Diameter of the lower tip 1.47mm Diameter of the cylindrical part 1.90mm
Published
2022-06-22
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
false

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
07640159162872PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640159162872076401591628727640159162872

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
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
true
Expiration date on label
false
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
08059388442911Prosthetic Over Post # 0OVERFIBERS SRLELR2025-03-12
08059388442928Prosthetic Over Post # 1OVERFIBERS SRLELR2025-03-12
08059388442935Prosthetic Over Post # 2OVERFIBERS SRLELR2025-03-12
08059388442942Prosthetic Over Post # 3OVERFIBERS SRLELR2025-03-12
08059388442959Prosthetic Over Post # 4OVERFIBERS SRLELR2025-03-12
08059388443215Over Post+ # 0OVERFIBERS SRLELR2025-03-12
08059388443222Over Post+ # 1OVERFIBERS SRLELR2025-03-12
08059388443239Over Post+ # 2OVERFIBERS SRLELR2025-03-12
08059388443246Over Post+ # 3OVERFIBERS SRLELR2025-03-12
08059388443253Over Post+ # 4OVERFIBERS SRLELR2025-03-12
08059388442966Endodontic Over Post # 0OVERFIBERS SRLELR2025-03-12
08059388442973Endodontic Over Post # 1OVERFIBERS SRLELR2025-03-12
08059388442980Endodontic Over Post # 2OVERFIBERS SRLELR2025-03-12
08059388442997Endodontic Over Post # 3OVERFIBERS SRLELR2025-03-12
08059388443000Endodontic Over Post # 4OVERFIBERS SRLELR2025-03-12
08059388443017Duo Over Post # 1OVERFIBERS SRLELR2025-03-12
08059388443024Duo Over Post # 2OVERFIBERS SRLELR2025-03-12
08059388442881Polygon Over Post # 1OVERFIBERS SRLELR2025-03-12
08059388442898Polygon Over Post # 2OVERFIBERS SRLELR2025-03-12
08059388442904Polygon Over Post # 3OVERFIBERS SRLELR2025-03-12
08059388443147Hi-Rem Prosthetic Post # 0OVERFIBERS SRLELR2025-03-12
08059388443154Hi-Rem Prosthetic Post # 1OVERFIBERS SRLELR2025-03-12
08059388443161Hi-Rem Prosthetic Post # 2OVERFIBERS SRLELR2025-03-12
08059388443178Hi-Rem Prosthetic Post # 3OVERFIBERS SRLELR2025-03-12
08059388443260Hi-Rem+ # 0OVERFIBERS SRLELR2025-03-12
08059388443277Hi-Rem+ # 1OVERFIBERS SRLELR2025-03-12
08059388443284Hi-Rem+ # 2OVERFIBERS SRLELR2025-03-12
08059388443291Hi-Rem+ # 3OVERFIBERS SRLELR2025-03-12
08059388443185Hi-Rem Endodontic Post # 1OVERFIBERS SRLELR2025-03-12
08059388443192Hi-Rem Endodontic Post # 2OVERFIBERS SRLELR2025-03-12