FDA UDI In Commercial Distribution 🇺🇸 United States

YAMAHACHI PMMA DISK

DI: 04582275719352 · Model: 95mm*14mm, A2 · YAMAHACHI DENTAL MFG.,CO.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
YAMAHACHI PMMA DISK
Primary DI
04582275719352
Version / Model
95mm*14mm, A2
Company Name
YAMAHACHI DENTAL MFG.,CO.
Labeler DUNS
693430001
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-04-10
Public Version
2
Public Version Date
2021-10-29
Public Version Status
Update
Public Device Record Key
86ebc7e4-94c2-4435-9dad-ce6b7ab7cea4

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
No

Product Codes

Code Name
EBG Crown And Bridge, Temporary, Resin

GMDN Terms

Code Name
45236 Temporary dental crown/bridge resin

Identifiers

Type ID
Primary 04582275719352

Premarket Submissions

Submission Number Supplement Number
K151764 000