FDA.report

CAMLOG® SCREW-LINE Implant, Promote® plus

Primary DI
E219K105643131
Brand
CAMLOG® SCREW-LINE Implant, Promote® plus
Company
ALTATEC GmbH
Model
K1056.4313
Catalog number
K1056.4313
Device description
CAMLOG® SCREW-LINE Implant, Promote® plus, snap-in, d 4.3 mm, l 13 mm
Published
2020-10-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications

CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E219K105643131PrimaryHIBCC0

GMDN Terms

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

TypeValueUnit
Length13Millimeter
Outer Diameter4.3Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
7609181857info@camlog.com

Regulatory Flags

DUNS number
322018193
Device count
1
DM exempt
false
Premarket exempt
false
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

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