FDA.reportPublic FDA data

Pilot drill Set

Primary DI
04099797012354
Brand
Pilot drill Set
Company
ALTATEC GmbH
Model
J5064.3316
Catalog number
J5064.3316
Device description
Guide Pilot drill, Ø 2 mm, internal irrigation Ø 3.3 mm, length 16.0 mm
Published
2026-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
E219J506433161PreviousHIBCC0
04099797012354PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04099797012354040997970123544099797012354

GMDN Terms#

Term, Definition table
TermDefinition
Fixture/appliance dental drill bit, single-useA shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a motorized handpiece or other power source that provides rotation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Outer Diameter0

Contacts#

Phone, Email table
PhoneEmail
+4970449445100info.de@camlog.com

Regulatory Flags#

DUNS number
322018193
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04099797000337CONELOG® SCREW-LINE ImplantC1065.3309C1065.33092026-08-17
04099797000344CONELOG® SCREW-LINE ImplantC1065.3311C1065.33112026-08-17
04099797000351CONELOG® SCREW-LINE ImplantC1065.3313C1065.33132026-08-17
04099797000368CONELOG® SCREW-LINE ImplantC1065.3316C1065.33162026-08-17
04099797000375CONELOG® SCREW-LINE ImplantC1065.3807C1065.38072026-08-17
04099797000382CONELOG® SCREW-LINE ImplantC1065.3809C1065.38092026-08-17
04099797000399CONELOG® SCREW-LINE ImplantC1065.3811C1065.38112026-08-17
04099797000405CONELOG® SCREW-LINE ImplantC1065.3813C1065.38132026-08-17
04099797000412CONELOG® SCREW-LINE ImplantC1065.3816C1065.38162026-08-17
04099797000429CONELOG® SCREW-LINE ImplantC1065.4307C1065.43072026-08-17
04099797000436CONELOG® SCREW-LINE ImplantC1065.4309C1065.43092026-08-17
04099797000443CONELOG® SCREW-LINE ImplantC1065.4311C1065.43112026-08-17
04099797000450CONELOG® SCREW-LINE ImplantC1065.4313C1065.43132026-08-17
04099797000467CONELOG® SCREW-LINE ImplantC1065.4316C1065.43162026-08-17
04099797000474CONELOG® SCREW-LINE ImplantC1065.5007C1065.50072026-08-17
04099797000481CONELOG® SCREW-LINE ImplantC1065.5009C1065.50092026-08-17
04099797000498CONELOG® SCREW-LINE ImplantC1065.5011C1065.50112026-08-17
04099797000504CONELOG® SCREW-LINE ImplantC1065.5013C1065.50132026-08-17
04099797000511CONELOG® SCREW-LINE ImplantC1065.5016C1065.50162026-08-17
04099797000528CONELOG® SCREW-LINE ImplantC1066.3309C1066.33092026-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776426736MillenniumAvalign Technologies, Inc.EJL2026-08-19
00190776426743MillenniumAvalign Technologies, Inc.EJL2026-08-19
04099797000726Drill for CT-tubeALTATEC GmbHEJL2026-08-17
04099797000733Drill for CT-tubeALTATEC GmbHEJL2026-08-17
04099797010664Surgery set CERALOG® PROGRESSIVE-LINE FlexALTATEC GmbHEJL2026-08-17
04099797011661Guide Template drillALTATEC GmbHEJL2026-08-17
04099797011678Guide Template drillALTATEC GmbHEJL2026-08-17
04099797011920Drill extensionALTATEC GmbHEJL2026-08-17
04099797012026Depth stopALTATEC GmbHEJL2026-08-17
04099797012033Depth stopALTATEC GmbHEJL2026-08-17
04099797012040Depth stopALTATEC GmbHEJL2026-08-17
04099797012057Depth stopALTATEC GmbHEJL2026-08-17
04099797012064Depth stopALTATEC GmbHEJL2026-08-17
04099797012071Depth stopALTATEC GmbHEJL2026-08-17
04099797012088Depth stopALTATEC GmbHEJL2026-08-17
04099797012095Depth stopALTATEC GmbHEJL2026-08-17
04099797012101Depth stopALTATEC GmbHEJL2026-08-17
04099797012118Point drillALTATEC GmbHEJL2026-08-17
04099797012125SCREW-LINE Form drillALTATEC GmbHEJL2026-08-17
04099797012132SCREW-LINE TapALTATEC GmbHEJL2026-08-17
04099797012361Pilot drill SetALTATEC GmbHEJL2026-08-17
04099797012378SCREW-LINE Form drillALTATEC GmbHEJL2026-08-17
04099797012385SCREW-LINE Form drillALTATEC GmbHEJL2026-08-17
04099797012392SCREW-LINE Form drillALTATEC GmbHEJL2026-08-17
04099797012408PROGRESSIVE-LINE Dense bone drillALTATEC GmbHEJL2026-08-17
04099797012415PROGRESSIVE-LINE Dense bone drillALTATEC GmbHEJL2026-08-17
04099797012422PROGRESSIVE-LINE Dense bone drillALTATEC GmbHEJL2026-08-17
04099797012439PROGRESSIVE-LINE Dense bone drillALTATEC GmbHEJL2026-08-17
04099797012446PROGRESSIVE-LINE Dense bone drill 2ALTATEC GmbHEJL2026-08-17
04099797012453PROGRESSIVE-LINE Dense bone drill 2ALTATEC GmbHEJL2026-08-17