FDA.reportPublic FDA data

MACRO-LOCK FINISHING DRILL 4

Primary DI
ERTDC060100000400000
Brand
MACRO-LOCK FINISHING DRILL 4
Company
RECHERCHES TECHNIQUES DENTAIRES
Model
4520124
Catalog number
4520124
Device description
Dental drill
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DZADRILL, DENTAL, INTRAORAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ERTD4520124012PackageHIBCC1In Commercial Distribution
ERTD4520124V001PackageHIBCC1In Commercial Distribution
ERTDC060100000400000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pin/post dental drill bitA shaft of metal, typically with a spiralled portion at the cutting end (a twist drill bit), intended to be attached to a motorized handpiece, or other power source, to create a precise round hole at the appropriate depth in teeth or bone of the oral cavity. This hole or slot is used to secure cast or preformed pins/posts for stabilizing and retaining operative dental appliances. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
260303508
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
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
ERTDC060100000500000MACRO-LOCK FINISHING DRILL 5452012545201252022-12-07
ERTDC060100000600000MACRO-LOCK FINISHING DRILL 6452012645201262022-12-07
ERTDFINITIONDRILLDT050D.T. LIGHT-POST UNIVERSAL DRILL 0.5152011015201102022-12-07

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