FDA UDI In Commercial Distribution 🇺🇸 United States

Titan Implant

DI: 07290111271083 · Model: I22-3.75,11.5 · A.B. DENTAL DEVICES LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Titan Implant
Primary DI
07290111271083
Version / Model
I22-3.75,11.5
Catalog Number
I22-3.75,11.5
Company Name
A.B. DENTAL DEVICES LTD
Labeler DUNS
534128491
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-05-05
Public Version
1
Public Version Date
2019-05-13
Public Version Status
New
Public Device Record Key
bf68592e-832f-4854-8e7a-4857cca98070

Device Description

Screw Type Implant, 3.75 mm Diameter, 11.5 mm lengh

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
No
Has Serial Number
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
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
Package 17290111271080
Primary 07290111271083

Customer Contacts

Device Sizes

Type Value Unit Text
Outer Diameter 3.75 Millimeter
Length 11.5 Millimeter