FDA.report

MACRO-LOCK POST ILLUSION X-RO INTROKIT

Primary DI
ERTD4590320013
Brand
MACRO-LOCK POST ILLUSION X-RO INTROKIT
Company
RECHERCHES TECHNIQUES DENTAIRES
Model
4590320
Published
2022-12-01
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
ERTD4590320013PrimaryHIBCC0

GMDN Terms

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

Regulatory Flags

DUNS number
260303508
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
ERTD1590312B012D.T. LIGHT-POST ILLUSION X-RO 21590312B1590312B2022-12-07
ERTD1590313B012D.T. LIGHT-POST ILLUSION X-RO 31590313B1590313B2022-12-07
ERTD1510310B012D.T. LIGHT-POST 0.51510310B1510310B2022-12-07
ERTD15100501BV001D.T. LIGHT-POST 11510311B1510311B2022-12-07
ERTD1510312B012D.T. LIGHT-POST 21510312B1510312B2022-12-07
ERTD15100503BV001D.T. LIGHT-POST 31510313B1510313B2022-12-07
ERTD1590310B012D.T. LIGHT-POST ILLUSION X-RO 0.51590310B1590310B2022-12-07
ERTD15900501BV001D.T. LIGHT-POST ILLUSION X-RO 11590311B1590311B2022-12-07
ERTD4590312B012MACRO-LOCK POST ILLUSION X-RO 24590312B4590312B2022-12-07
ERTD4590313B012MACRO-LOCK POST ILLUSION X-RO 34590313B4590313B2022-12-07
ERTD45900504BV001MACRO-LOCK POST ILLUSION X-RO 44590314B4590314B2022-12-07
ERTD4590315B012MACRO-LOCK POST ILLUSION X-RO 54590315B4590315B2022-12-07
ERTD45900506BV001MACRO-LOCK POST ILLUSION X-RO 64590316B4590316B2022-12-07
ERTD4520122012MACRO-LOCK FINISHING DRILL 2452012245201222022-12-07
ERTD4520123012MACRO-LOCK FINISHING DRILL 3452012345201232022-12-07
ERTD4520124012MACRO-LOCK FINISHING DRILL 4452012445201242022-12-07
ERTD4520125012MACRO-LOCK FINISHING DRILL 5452012545201252022-12-07
ERTD4520126V001MACRO-LOCK FINISHING DRILL 6452012645201262022-12-07
ERTD1520110V001D.T. LIGHT-POST UNIVERSAL DRILL 0.5152011015201102022-12-07
ERTD1520111V001D.T. LIGHT-POST FINISHING DRILL 1152011115201112022-12-07

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