FDA.reportPublic FDA data

Spiral Drill

Primary DI
04099797994599
Brand
Spiral Drill
Company
ALTATEC GmbH
Model
J5036.0820
Catalog number
J5036.0820
Device description
Spiral drill, reverse action, Ø 0.82 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
E219J503608201PreviousHIBCC0
04099797994599PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04099797994599040997979945994099797994599

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant extractorA manually-operated, one-piece dental device intended to be used to retrieve an in situ dental implant [i.e., anchorage and/or retention (abutment) component], typically because of damage (e.g., a broken collar) or malfunction, from the oral cavity. It typically has a cylindrical design and a cavity or threaded shaft at the working distal end intended to grip or be inserted into the implant. It may have a handle at the proximal end or be used in conjunction with a drill and/or a separate handle or wrench (not included); it is not a collection of devices (i.e., not a kit). This is a single-use device.

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
04099797000726Drill for CT-tubeA2050.2600A2050.26002026-08-17
04099797000733Drill for CT-tubeA2050.2800A2050.28002026-08-17
04099797009200CONELOG® / iSy® Bonding aidC4019.1600C4019.16002026-08-17
04099797009217CONELOG® / iSy® Bonding aidC4019.2000C4019.20002026-08-17
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

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00810226101043AiraAIRA, LLCEJL2026-08-25
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00810226101081AiraAIRA, LLCEJL2026-08-25