FDA.reportPublic FDA data

Guide Form drill, SL

Primary DI
E219J506843071
Brand
Guide Form drill, SL
Company
ALTATEC GmbH
Model
J5068.4307
Catalog number
J5068.4307
Device description
Guide Form drill, SL, cortical bone Ø 4.3 mm L 7.0 mm Ø 4.3 L 7.0
Published
2023-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
E219J506843071PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

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
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E219J590020001Universal cone disconnectorJ5900.2000J5900.20002026-02-10
E219K590133001CAMLOG® Connection Reamer SetK5901.3300K5901.33002026-02-10
E219K590138001CAMLOG® Connection Reamer SetK5901.3800K5901.38002026-02-10
E219K590143001CAMLOG® Connection Reamer SetK5901.4300K5901.43002026-02-10
E219K590150001CAMLOG® Connection Reamer SetK5901.5000K5901.50002026-02-10
E219J508133091Guide dense bone drill 2, PLJ5081.3309J5081.33092025-05-13
E219J508133111Guide dense bone drill 2, PLJ5081.3311J5081.33112025-05-13
E219J508133131Guide dense bone drill 2, PLJ5081.3313J5081.33132025-05-13
E219J508133161Guide dense bone drill 2, PLJ5081.3316J5081.33162025-05-13
E219J508138071Guide dense bone drill 2, PLJ5081.3807J5081.38072025-05-13
E219J508138091Guide dense bone drill 2, PLJ5081.3809J5081.38092025-05-13
E219J508138111Guide dense bone drill 2, PLJ5081.3811J5081.38112025-05-13
E219J508138131Guide dense bone drill 2, PLJ5081.3813J5081.38132025-05-13
E219J508138161Guide dense bone drill 2, PLJ5081.3816J5081.38162025-05-13
E219J508143071Guide dense bone drill 2, PLJ5081.4307J5081.43072025-05-13
E219J508143091Guide dense bone drill 2, PLJ5081.4309J5081.43092025-05-13
E219J508143111Guide dense bone drill 2, PLJ5081.4311J5081.43112025-05-13
E219J508143131Guide dense bone drill 2, PLJ5081.4313J5081.43132025-05-13
E219J508143161Guide dense bone drill 2, PLJ5081.4316J5081.43162025-05-13
E219J508150071Guide dense bone drill 2, PLJ5081.5007J5081.50072025-05-13

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