FDA UDI Not in Commercial Distribution 🇺🇸 United States

DS PrimeTaper

DI: 07392532270079 · Model: 68011086 · Dentsply Implants Manufacturing GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
DS PrimeTaper
Primary DI
07392532270079
Version / Model
68011086
Catalog Number
68011086
Company Name
Dentsply Implants Manufacturing GmbH
Labeler DUNS
344038836
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-12-16
Public Version
3
Public Version Date
2023-08-30
Public Version Status
Update
Public Device Record Key
225fea70-6102-45e1-9dab-db8f829fa30e
Distribution End Date
2023-08-30

Device Description

PrimeTaper EV Ø3.0 x 9mm OsseoSpeed

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
MR Conditional
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
DZE IMPLANT, ENDOSSEOUS, ROOT-FORM

GMDN Terms

Code Name
55849 Screw endosteal dental implant, two-piece

Identifiers

Type ID
Primary 07392532270079