FDA UDI In Commercial Distribution 🇺🇸 United States

MULTI-CAL™

DI: D701MULTI2 · Model: MULTI · PULPDENT CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
MULTI-CAL™
Primary DI
D701MULTI2
Version / Model
MULTI
Company Name
PULPDENT CORPORATION
Labeler DUNS
001006089
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-01
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
9a7e9242-639b-4867-98bd-f9b8eedb5001

Device Description

CALCIUM HYDROXIDE PASTE, RADIOPAQUE Kit: 4 x 1.2 mL syringes + 8 applicator tips

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
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
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EJK Liner, Cavity, Calcium Hydroxide

GMDN Terms

Code Name
38770 Dental pulp-capping material

Identifiers

Type ID
Primary D701MULTI2

Device Sizes

Type Value Unit Text
Total Volume 1.2 Milliliter