FDA.reportPublic FDA data

Surgery set, SL

Primary DI
E219J530000611
Brand
Surgery set, SL
Company
ALTATEC GmbH
Model
J5300.0061
Catalog number
J5300.0061
Device description
Surgery set SCREW-LINE
Published
2023-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
E219J530000611PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental/maxillofacial surgical procedure kit, non-medicated, reusableA collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
7609181857info@camlog.com

Regulatory Flags#

DUNS number
322018193
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
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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00810194409554AiraAIRA, LLCEJL2026-08-25
00810194409585AiraAIRA, LLCEJL2026-08-25
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00810226101043AiraAIRA, LLCEJL2026-08-25
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