FDA UDI In Commercial Distribution 🇺🇸 United States

UltraPrint-Dental Temp C&B UV

DI: 06971437940372 · Model: 2.0 · GUANGZHOU HEYGEARS IMC.INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
UltraPrint-Dental Temp C&B UV
Primary DI
06971437940372
Version / Model
2.0
Company Name
GUANGZHOU HEYGEARS IMC.INC
Labeler DUNS
418561545
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-01-19
Public Version
1
Public Version Date
2022-01-27
Public Version Status
New
Public Device Record Key
cc2fe887-6a15-414c-afb9-46c93da8985a

Device Description

UltraPrint-Dental Temp C&B UV, 1000g/bottle, A1

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
MR Safe
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
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 06971437940372

Premarket Submissions

Submission Number Supplement Number
K213643 000