Primary Device ID | D810PCSRSEK11 |
NIH Device Record Key | 644279e4-a749-483f-a129-49ed822e341a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CLEARSPLINT |
Version Model Number | PCSRSEK1 |
Catalog Number | PCSRSEK1 |
Company DUNS | 056624901 |
Company Name | ASTRON DENTAL CORPORATION |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | true |
Phone | 847-726-8787 |
ASTRONCORP@AOL.COM | |
Phone | 847-726-8787 |
ASTRONCORP@AOL.COM |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D810PCSRSEK11 [Primary] |
MQC | Mouthguard, Prescription |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2018-09-24 |
Device Publish Date | 2016-09-07 |
D810PCSRSEK11 | DENTURE MATERIAL - SUPER ECONO KIT - PACKAGE 960 GRAMS POWDER/3 EACH 240 GRAMS LIQUID |
D810PCSRLK11 | DENTURE MATERIAL - PACKAGE 160 GRAMS POWDER/120 GRAMS LIQUID |
D810PCSREK11 | DENTURE MATERIAL - PACKAGE 320 GRAMS POWDER / 240 GRAMS LIQUID |
D810PCSFSEK11 | DENTURE MATERIAL - SUPER ECONO KIT - PACKAGE 960 GRAMS POWDER/ 3 EACH 240 GRAMS LIQUID |
D810PCSFLK11 | DENTURE MATERIAL - PACKAGE 160 GRAMS POWDER/120 GRAMS LIQUID |
D810PCSFEK11 | DENTURE MATERIAL - PACKAGE 320 GRAMS POWDER / 240 GRAMS LIQUID |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() CLEARSPLINT 85536757 4205792 Live/Registered |
Astron Dental Corporation 2012-02-08 |
![]() CLEARSPLINT 73383719 not registered Dead/Abandoned |
HOWE, RAYMOND P. 1982-09-07 |