FDA.report

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
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
DZADRILL, DENTAL, INTRAORAL

Product Code Classifications

CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
ERTD46900004013PrimaryHIBCC0

GMDN Terms

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

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

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