FDA.reportPublic FDA data

X-Ray planning foil CAMLOG® PROGRESSIVE-LINE Implants

Primary DI
E219K530090141
Brand
X-Ray planning foil CAMLOG® PROGRESSIVE-LINE Implants
Company
ALTATEC GmbH
Model
K5300.9014
Catalog number
K5300.9014
Device description
X-Ray planning foil 1.25:1, CAMLOG® PROGRESSIVE-LINE Implants
Published
2020-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E219K530090141PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant x-ray templateA non-sterile device intended to be used by a dentist or a surgeon to radiographically determine the appropriate size of a dental implant to be inserted into the jawbone of a patient prior to dental surgery. It is typically made of a translucent plastic sheet marked with incremented graduations that correspond to the lengths of the implants available. The device is typically available in a set with graduated markings and an individual sheet is placed over the x-ray of the jawbone so that the final selection of implant size can be determined against the depth of bone shown by the x-ray. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7609181857info@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
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
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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