FDA UDI In Commercial Distribution 🇺🇸 United States

SET ZZ BASE NB-B-WSM 3.5

DI: D800ZBCD0231 · Model: ZBCD0231 · ZIRKONZAHN SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
SET ZZ BASE NB-B-WSM 3.5
Primary DI
D800ZBCD0231
Version / Model
ZBCD0231
Company Name
ZIRKONZAHN SRL
Labeler DUNS
564251911
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-09-24
Public Version
1
Public Version Date
2020-10-02
Public Version Status
New
Public Device Record Key
27a119b9-0d93-46ee-8753-7b374ca3ab3a

Device Description

SET ZZ BASE NB-B-WSM 3.5 (White Scanmarker and screw). The ZZ BASE WSM (WHITE SCANMARKER) allows the user to record the implant position and inclination in the patient’s mouth or on the model.

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
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
NDP Accessories, Implant, Dental, Endosseous

GMDN Terms

Code Name
61641 Dental implant abutment analog, scanning

Identifiers

Type ID
Primary D800ZBCD0231