FDA.report

DS PrimeTaper

Primary DI
07392532276743
Brand
DS PrimeTaper
Company
Dentsply Implants Manufacturing GmbH
Model
68011101
Catalog number
68011101
Device description
PrimeTaper EV Ø4.2 x 15mm OsseoSpeed
Published
2023-02-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM

Product Code Classifications

CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07392532276743PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07392532276743073925322767437392532276743

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
344038836
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
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

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07392532281280ATLANTIS®68020076680200762025-12-18
07392532215278ANKYLOS®31021100310211002020-11-18
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07392532215865ANKYLOS®31021630310216302020-11-18
07392532215896ANKYLOS®31021647310216472020-11-18
07392532215988ANKYLOS®31021660310216602020-11-18
07392532216572ANKYLOS®31022540310225402020-11-18

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