FDA UDI In Commercial Distribution 🇺🇸 United States

6 x 15mm Simpli Simpler One Piece GBAE Dental Implant

DI: D780S1S36150 · Model: S1S 3615 · Simpler Implant Solutions Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
6 x 15mm Simpli Simpler One Piece GBAE Dental Implant
Primary DI
D780S1S36150
Version / Model
S1S 3615
Catalog Number
S1S 3615
Company Name
Simpler Implant Solutions Inc
Labeler DUNS
203213343
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2015-11-06
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
67bd1a48-fa2d-440a-a190-2c1edceb793f

Device Description

6 x 15mm Simpli Simpler One Piece Grit Blasted Acid Etched Dental Implant for Crown and Bridge

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
Yes
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
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
Yes
Sterilization Methods
Radiation Sterilization

Product Codes

Code Name
DZE Implant, Endosseous, Root-Form

GMDN Terms

Code Name
55848 Screw endosteal dental implant, one-piece

Identifiers

Type ID
Primary D780S1S36150