FDA.reportPublic FDA data

CAMLOG® SCREW-LINE Implant, Promote® plus

Primary DI
E219K105238091
Brand
CAMLOG® SCREW-LINE Implant, Promote® plus
Company
ALTATEC GmbH
Model
K1052.3809
Catalog number
K1052.3809
Device description
K1052.3809 CAMLOG® SCREW-LINE Implant, Promote® plus, d=3.8mm, l=9mm
Published
2015-09-24
Public version status
Update
Distribution status
Not 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
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E219K105238091PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, two-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length9Millimeter
Lumen/Inner Diameter3.8Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7609181857info@camlog.com

Regulatory Flags#

DUNS number
322018193
Device count
1
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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Primary DI, Brand, Company table
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