FDA.reportPublic FDA data

MACRO-LOCK OVAL INTRO KIT B

Primary DI
ERTD46900004013
Brand
MACRO-LOCK OVAL INTRO KIT B
Company
RECHERCHES TECHNIQUES DENTAIRES
Model
46900004
Catalog number
46900004
Published
2022-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
ERTD46900004013PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic enlarger, reusableA manual dental instrument designed to be used to access the root canal and to enlarge the opening of the coronal portion of the root canal. This is a reusable 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
ERTD4590320013MACRO-LOCK POST ILLUSION X-RO INTROKIT45903202022-12-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887919581727DENTFLEX FIBER POSTPeter Brasseler Holdings, LLCDZA2026-09-25
00887919581741DENTFLEX FIBER POSTPeter Brasseler Holdings, LLCDZA2026-09-25
00887919581765DENTFLEX FIBER POSTPeter Brasseler Holdings, LLCDZA2026-09-25
08800394921293Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921309Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921316Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921323Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921330Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921347Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921354Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921361Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921378Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921385Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921392Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921408Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921415Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921422Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921439Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921446Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921453Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921460Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921477Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08059224218007INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218014INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218038INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218250INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
06942686761223DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761230DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761247DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761254DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21