| Primary Device ID | D6501356PT0 |
| NIH Device Record Key | 38c6e5ff-bec4-4fd3-8db1-7d3ff449605b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ORTHO-JET |
| Version Model Number | FIVE POUND PACKAGE PINK TINT |
| Catalog Number | 1356PT |
| Company DUNS | 005185798 |
| Company Name | LANG DENTAL MANUFACTURING CO., INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | D6501356PT0 [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 | 2023-07-05 |
| Device Publish Date | 2023-06-27 |
| D650PTA10 - PULSETEMP | 2026-01-23 SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL |
| D650PTA20 - PULSETEMP | 2026-01-23 SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL |
| D650PTA30 - PULSETEMP | 2026-01-23 SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL |
| D6500270C0 - ORTHO-JET CRYSTAL POWDER | 2023-07-05 FAST CURING EXTRA CLEAR ORTHODONTIC ACRYLIC RESIN POWDER |
| D6500934F10 - FLEXACRYL HARD | 2023-07-05 DENTURE RELINE ACRYLIC POWDER AND LIQUID |
| D6500950CLR0 - FLEXACRYL | 2023-07-05 DENTURE RELINE ACRYLIC RESIN POWDER |
| D6501070P10 - TEMPO POWDER | 2023-07-05 CUSHION TREATMENT DENTURE REPAIR RELINE ACRYLIC RESIN POWDER |
| D6501330LS0 - ORTHO-JET POWDER | 2023-07-05 FAST CURING ORTHODONTIC ACRYLIC RESIN POWDER |