FDA.report

Radix-Anker® Standard Set

Primary DI
J003C195DT00000001
Brand
Radix-Anker® Standard Set
Company
MAILLEFER INSTRUMENTS HOLDING Sàrl
Model
C195DT0000000
Catalog number
C195DT0000000
Device description
Endodontic Posts Set - Dr Spang
Published
2022-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
ELRPOST, ROOT CANAL

Product Code Classifications

CodeDeviceSpecialtyClass
ELRPost, Root CanalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
J003C195DT00000001PrimaryHIBCC0

GMDN Terms

TermDefinition
Root canal post kitA collection of dental devices intended for use during insertion of a root canal post(s), sometimes with core build-up. This device typically includes a prefabricated root canal post(s), drill(s), thread cutter, and may include core-build-up materials such as applicator (dispensing gun), dental composite resin(s), dentine bonding agent, and etching solution. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00N/A

Sterilization Methods

Method

Regulatory Flags

DUNS number
480538495
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
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 DIBrandModelCatalogPublished
J003TNSRMGPF000200Reciproc MinimaTNSRMGPF00020TNSRMGPF000202025-07-02
J003TNSRMGPF000250Reciproc MinimaTNSRMGPF00025TNSRMGPF000252025-07-02
J003TNSRMGPF000350Reciproc MinimaTNSRMGPF00035TNSRMGPF000352025-07-02
J003TNSRMGPF000450Reciproc MinimaTNSRMGPF00045TNSRMGPF000452025-07-02
J003TNSRMGPF00AST0Reciproc MinimaTNSRMGPF00ASTTNSRMGPF00AST2025-07-02
J003E055034102B001CFE014924101600E055034102B002022-12-08
J003TSTRMPPM00AST1Reciproc MinimaTSTRMPPM00ASTTSTRMPPM00AST2025-08-05
J003TDDRCPM621AST1Reciproc MinimaTDDRCPM621ASTTDDRCPM621AST2025-07-22
J003TDDRCPM6250201Reciproc MinimaTDDRCPM625020 TDDRCPM625020 2025-07-22
J003TDDRCPM6250251Reciproc MinimaTDDRCPM625025TDDRCPM6250252025-07-22
J003TDDRCPM6250351Reciproc MinimaTDDRCPM625035TDDRCPM6250352025-07-22
J003TDDRCPM6250451Reciproc MinimaTDDRCPM625045TDDRCPM6250452025-07-22
J003TDDRCPM625AST1Reciproc MinimaTDDRCPM625ASTTDDRCPM625AST2025-07-22
J003TDDRCPM631AST1Reciproc MinimaTDDRCPM631ASTTDDRCPM631AST2025-07-22
J003TSTRCPM621021Reciproc MinimaTSTRCPM621020 TSTRCPM621020 2025-07-22
J003TSTRCPM6210251Reciproc MinimaTSTRCPM621025 TSTRCPM621025 2025-07-22
J003TSTRCPM6210351Reciproc MinimaTSTRCPM621035TSTRCPM6210352025-07-22
J003TSTRCPM6210451Reciproc MinimaTSTRCPM621045TSTRCPM6210452025-07-22
J003TSTRCPM621AST1Reciproc MinimaTSTRCPM621ASTTSTRCPM621AST2025-07-22
J003TSTRCPM6250201Reciproc MinimaTSTRCPM625020 TSTRCPM625020 2025-07-22

Other Devices Sharing Product Codes

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