Primary Device ID | D6501020P10 |
NIH Device Record Key | b82488b3-6b3f-4568-8270-f83a5f8a573e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | TEMPO |
Version Model Number | 100 GRAMS P1 |
Catalog Number | 1020P1 |
Company DUNS | 005185798 |
Company Name | LANG DENTAL MANUFACTURING CO., INC. |
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 | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D6501020P10 [Primary] |
EBI | Resin, Denture, Relining, Repairing, Rebasing |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-04-25 |
Device Publish Date | 2022-04-15 |
D6501050P10 | CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN POWDER |
D6501034P10 | CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN POWDER AND LIQUID |
D6501030P10 | CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN POWDER |
D6501023P10 | CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN POWDER AND LIQUID |
D6501020P10 | CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN POWDER |