FDA UDI In Commercial Distribution 🇺🇸 United States

myTines Prime

DI: E29968920 · Model: 6892 · Polydentia SA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6

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Basic Information

Brand Name
myTines Prime
Primary DI
E29968920
Version / Model
6892
Catalog Number
6892
Company Name
Polydentia SA
Labeler DUNS
481461598
Distribution Status
In Commercial Distribution
Device Count in Pkg
6
Record Status
Published
Publish Date
2025-06-16
Public Version
1
Public Version Date
2025-06-24
Public Version Status
New
Public Device Record Key
d76cb4cd-77d4-4337-af27-fec462ec97e5

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
No
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
DZN Instruments, Dental Hand

GMDN Terms

Code Name
33204 Dental matrix band retainer

Identifiers

Type ID
Unit of Use E29968929
Primary E29968920