FDA UDI In Commercial Distribution 🇺🇸 United States

Compo-Dots Composite Condensing Dots Firm

DI: 00723896010716 · Model: 13113 · PRACTICON, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100

Basic Information

Brand Name
Compo-Dots Composite Condensing Dots Firm
Primary DI
00723896010716
Version / Model
13113
Catalog Number
71-05712
Company Name
PRACTICON, INC.
Labeler DUNS
119193803
Distribution Status
In Commercial Distribution
Device Count in Pkg
100
Record Status
Published
Publish Date
2018-07-19
Public Version
2
Public Version Date
2018-11-08
Public Version Status
Update
Public Device Record Key
5a993053-ece9-4fa1-8c32-7e082b73e6e0

Device Description

Firm Compo-Dots help condense higher viscosity composites more easily. Ideal for use with Class I, II and III preps.

Device Characteristics

Single Use
Yes
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
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
DZN Instruments, Dental Hand

GMDN Terms

Code Name
35697 Dental material application tool, single-use

Identifiers

Type ID
Primary 00723896010716
Unit of Use 00723896003114