FDA UDI In Commercial Distribution 🇺🇸 United States

Alpine Dental

DI: D922VPSAD1011 · Model: AD101 · ALPINE DENTAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Alpine Dental
Primary DI
D922VPSAD1011
Version / Model
AD101
Catalog Number
VPSAD101
Company Name
ALPINE DENTAL INC.
Labeler DUNS
037301378
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-12-13
Public Version
1
Public Version Date
2019-12-23
Public Version Status
New
Public Device Record Key
127816bd-09a6-47be-aa64-59b1aa8a5617

Device Description

Vinyl Polysiloxane Impression Cartridge, Injection, Fast Set, 50ml (1)

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
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
ELW Material, Impression

GMDN Terms

Code Name
35866 Silicone dental impression material

Identifiers

Type ID
Primary D922VPSAD1011
Package D922VPSAD1001