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
00840456224496JMUJMU DENTAL, INCDZA2026-07-29
00840456224502JMUJMU DENTAL, INCDZA2026-07-29
00840456224519JMUJMU DENTAL, INCDZA2026-07-29
00840456224526JMUJMU DENTAL, INCDZA2026-07-29
00840456224533JMUJMU DENTAL, INCDZA2026-07-29
00840456224540JMUJMU DENTAL, INCDZA2026-07-29
00840456224557JMUJMU DENTAL, INCDZA2026-07-29
00840456224564JMUJMU DENTAL, INCDZA2026-07-29
08806343926302Sinus KitShinhung MST Co., Ltd.DZA2026-07-29
08806343926319Sinus KitShinhung MST Co., Ltd.DZA2026-07-29
08806343926326Sinus KitShinhung MST Co., Ltd.DZA2026-07-29
08806343926333Sinus KitShinhung MST Co., Ltd.DZA2026-07-29
08806343926340Sinus KitShinhung MST Co., Ltd.DZA2026-07-29
08806343926357Sinus KitShinhung MST Co., Ltd.DZA2026-07-29
08806343926364Sinus KitShinhung MST Co., Ltd.DZA2026-07-29
08806343926371Sinus KitShinhung MST Co., Ltd.DZA2026-07-29
08800070248706Short DrillIzenimplant Co., Ltd.DZA2026-07-27
08800070248713Short DrillIzenimplant Co., Ltd.DZA2026-07-27
08800070248720Short DrillIzenimplant Co., Ltd.DZA2026-07-27
08800070248737Short DrillIzenimplant Co., Ltd.DZA2026-07-27
08800070248744Short DrillIzenimplant Co., Ltd.DZA2026-07-27
08800070248751Short DrillIzenimplant Co., Ltd.DZA2026-07-27
07290116660677Surgical DrillsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZA2026-07-12
07290116154787Dental DrillsNORIS MEDICAL LTDDZA2026-07-09
07290116154794Diamond BurrsNORIS MEDICAL LTDDZA2026-07-09
088000702492151.2 Hex Angled Machine Screw DriverIzenimplant Co., Ltd.DZA2026-06-22
06932195393831DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393848DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393855DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393879DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10