FDA.reportPublic FDA data

Pilot Drill 2mmD x 16mmL Ext.

Primary DI
07290105156457
Brand
Pilot Drill 2mmD x 16mmL Ext.
Company
ADIN DENTAL IMPLANT SYSTEMS LTD
Model
RS8001
Published
2017-04-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EJLBur, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290105156457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290105156457072901051564577290105156457

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
533289435
Device count
1
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
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07290109308609Single TMA Plastic Casting Sleeve w/Prosthetic ScrewRS5001S2026-05-11
07290109308616Single TMA ReplicaRS5004S2026-05-11
07290109308647Single TMA Closed Tray TransferRS5011S2026-05-11
07290109308630Single TMA Open Tray TransferRS5006S2025-12-15
07290116778662Zygomatic Surgical Kit, Standard Hex ZGSK0012026-04-19
07290105150004Touareg CloseFit™ Plastic Surgical Kit-PremiumCF63002017-04-23
07290105150028Touareg CloseFit™ Plastic Surgical Kit-AdvancedCF63022017-04-23
07290105150035Touareg CloseFit™ Plastic Surgical Kit-StarterCF63032017-04-23
07290105150042Touareg CloseFit™ Plastic Surgical Kit-Advanced Short DrillsCF63042017-04-23
07290105150059Touareg CloseFit™ Plastic Surgical Kit-Starter Short DrillsCF63052017-04-23
07290105155429RS Angled Trans Mucosal Abutment 45° 4mmRS37362026-03-26
07290109309293Touareg™ OS Zygomatic Dental Implant 4.2D 35LISZT35422026-03-26
07290109309309Touareg™ OS Zygomatic Dental Implant 4.2D 37.5LISZT37422026-03-26
07290109309316Touareg™ OS Zygomatic Dental Implant 4.2D 40LISZT40422026-03-26
07290109309323Touareg™ OS Zygomatic Dental Implant 4.2D 42.5LISZT42422026-03-26
07290109309330Touareg™ OS Zygomatic Dental Implant 4.2D 45LISZT45422026-03-26
07290109309347Touareg™ OS Zygomatic Dental Implant 4.2D 47.5LISZT47422026-03-26
07290109309354Touareg™ OS Zygomatic Dental Implant 4.2D 50LISZT50422026-03-26
07290109309361Touareg™ OS Zygomatic Dental Implant 4.2D 52.5LISZT52422026-03-26
07290109309378Touareg™ OS Zygomatic Dental Implant 4.2D 55LISZT55422026-03-26

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