Primary Device ID | D90980014717 |
NIH Device Record Key | 14640b52-1d42-4cfd-847b-5b1de828aecf |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CLOSING TOOL |
Version Model Number | 800-147 |
Catalog Number | 800-147 |
Company DUNS | 020956330 |
Company Name | Ortho Arch Company 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 | false |
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 | D90980014717 [Primary] |
JEX | Plier, Orthodontic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-07-06 |
Device Publish Date | 2023-06-28 |
D90970000913 - ORTHO ARCH | 2025-09-05 WIRE BONDER SMALL TIPS & HANDLE (10 TIPS) |
D9097000111 - ORTHO ARCH | 2025-09-05 BRACKET BONDER TIPS & HANDLE (10 TIPS) |
D9097001011 - ORTHO ARCH | 2025-09-05 MINI MOLD INTRO KIT |
D9097001021 - ORTHO ARCH | 2025-09-05 Mini Mold Universal Bite Opening Kit |
D90970010M1 - ORTHO ARCH | 2025-09-05 MINI MOLD STARTER KIT 30 TIPS |
D9097001111 - ORTHO ARCH | 2025-09-05 MINI MOLD PEG LATERAL 4 TIP KIT |
D90970011511 - ORTHO ARCH | 2025-09-05 ANTERIOR BITE JET 7MM TIPS (8) |
D90970011713 - ORTHO ARCH | 2025-09-05 ANTERIOR BITE RAMP 3MM TIPS & HANDLE (8) |