FDA.reportPublic FDA data

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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZADRILL, DENTAL, INTRAORAL
ELRPOST, ROOT CANAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1
ELRPost, Root CanalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ERTD4590320013PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
260303508
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
ERTDC060100000300000MACRO-LOCK FINISHING DRILL 3452012345201232022-12-07
ERTDAE1ILLUSIONXRO000MACRO-LOCK POST ILLUSION X-RO 14590311B4590311B2022-12-16
ERTD10008ILLUXROJAUN0D.T. LIGHT-POST ILLUSION X-RO 21590312B1590312B2022-12-07
ERTD12010ILLUXROBLEU0D.T. LIGHT-POST ILLUSION X-RO 31590313B1590313B2022-12-07
ERTD1510000V000D.T. LIGHT-POST 0.51510310B1510310B2022-12-07
ERTD1510001V000D.T. LIGHT-POST 11510311B1510311B2022-12-07
ERTD1510002V000D.T. LIGHT-POST 21510312B1510312B2022-12-07
ERTD1510003V000D.T. LIGHT-POST 31510313B1510313B2022-12-07
ERTD8004ILLUXRONOIR0D.T. LIGHT-POST ILLUSION X-RO 0.51590310B1590310B2022-12-07
ERTD9006ILLUXROROUGE0D.T. LIGHT-POST ILLUSION X-RO 11590311B1590311B2022-12-07
ERTDAE2ILLUSIONXRO000MACRO-LOCK POST ILLUSION X-RO 24590312B4590312B2022-12-07
ERTDAE3ILLUSIONXRO000MACRO-LOCK POST ILLUSION X-RO 34590313B4590313B2022-12-07
ERTDAE4ILLUSIONXRO000MACRO-LOCK POST ILLUSION X-RO 44590314B4590314B2022-12-07
ERTDAE5ILLUSIONXRO000MACRO-LOCK POST ILLUSION X-RO 54590315B4590315B2022-12-07
ERTDAE6ILLUSIONXRO000MACRO-LOCK POST ILLUSION X-RO 64590316B4590316B2022-12-07
ERTDC060100000200000MACRO-LOCK FINISHING DRILL 2452012245201222022-12-07
ERTDC060100000400000MACRO-LOCK FINISHING DRILL 4452012445201242022-12-07
ERTDC060100000500000MACRO-LOCK FINISHING DRILL 5452012545201252022-12-07
ERTDC060100000600000MACRO-LOCK FINISHING DRILL 6452012645201262022-12-07
ERTDFINITIONDRILLDT050D.T. LIGHT-POST UNIVERSAL DRILL 0.5152011015201102022-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06947600328834Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L5mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328841Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L8mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328858Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L10mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328865Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L12mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328872Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L14mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328889Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L16mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328896Expander Drill,BLT,Φ2.8mm/Φ5.0mm,L8mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328902Expander Drill,BLT,Φ2.8mm/Φ5.0mm,L10mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328919Expander Drill,BLT,Φ2.8mm/Φ5.0mm,L12mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328926Expander Drill,BLT,Φ2.8mm/Φ5.0mm,L14mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328933Expander Drill,BLT,Φ2.8mm/Φ5.0mm,L16mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328940Expander Drill,BLT,Φ3.5mm/Φ5.0mm,L8mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328957Expander Drill,BLT,Φ3.5mm/Φ5.0mm,L10mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328964Expander Drill,BLT,Φ3.5mm/Φ5.0mm,L12mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328971Expander Drill,BLT,Φ3.5mm/Φ5.0mm,L14mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328988Expander Drill,BLT,Φ3.5mm/Φ5.0mm,L16mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328995Expander Drill,BLT,Φ4.2mm/Φ5.0mm,L8mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600329008Expander Drill,BLT,Φ4.2mm/Φ5.0mm,L10mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600329015Expander Drill,BLT,Φ4.2mm/Φ5.0mm,L12mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600329022Expander Drill,BLT,Φ4.2mm/Φ5.0mm,L14mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600329039Expander Drill,BLT,Φ4.2mm/Φ5.0mm,L16mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600329046Profile Drill,BLT,Φ3.3mm, L33mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600329060Profile Drill,BLT,Φ4.1mm, L33mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600329084Profile Drill,BLT,Φ4.8mm, L33mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
07899878064985NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878064992NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065005NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065012NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065029NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065036NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18