FDA UDI In Commercial Distribution 🇺🇸 United States

DiamoDent

DI: D907A12000 · Model: N/A · DIAMODENT INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
DiamoDent
Primary DI
D907A12000
Version / Model
N/A
Catalog Number
A1200
Company Name
DIAMODENT INC
Labeler DUNS
013827410
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-06-29
Public Version
1
Public Version Date
2020-07-07
Public Version Status
New
Public Device Record Key
c40e4086-627e-44a3-9262-e48e45ec32cf

Device Description

Scan Body, Medical Grade PEEK & Titanium Compatible with: - 3.75 & 4mm Regular Platform (RP) Branemark implants -3.75 & 4mm Standard BIOMET 3i implants -3.8 & 4.5mm HL Steri-Oss implants

Device Characteristics

Single Use
No
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
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Dry Heat Sterilization

Product Codes

Code Name
DZE Implant, Endosseous, Root-Form

GMDN Terms

Code Name
46122 Dental implant suprastructure, temporary, preformed, reusable

Identifiers

Type ID
Primary D907A12000