Ortho Organizers
GUDID 00190707009229
Facebow Straight Standard
ORTHO ORGANIZERS, INC.
Orthodontic face bow| Primary Device ID | 00190707009229 |
| NIH Device Record Key | accdd9a6-7977-4720-97a6-ce40325213f1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ortho Organizers |
| Version Model Number | 425-016A |
| Company DUNS | 062165188 |
| Company Name | ORTHO ORGANIZERS, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190707009229 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K980195
FDA Product Code
| DZB | Headgear, extraoral, orthodontic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [Ortho Organizers]
| 00190707054472 | NITANIUM MOLAR DISTALIZING SPRING |
| 00190707054465 | .016 ANTERIOR TORQUING SPRING |
| 00190707054458 | .0195 STAINLESS STEEL STANDARD TWIST ARCHWIRE |
| 00190707054441 | .0175 STAINLESS STEEL STANDARD TWIST ARCHWIRE |
| 00190707054434 | .015 STAINLESS STEEL STANDARD TWIST ARCHWIRE |
| 00190707054427 | VERTICAL SLOT ROTATION SPRINGS MEDIUM CLOCKWISE |
| 00190707054410 | VERTICAL SLOT ROTATION SPRINGS MEDIUM COUNTER-CLOCKWISE |
| 00190707054403 | VERTICAL SLOT ROTATION SPRINGS SHORT CLOCKWISE |
| 00190707054397 | VERTICAL SLOT ROTATION SPRINGS SHORT COUNTER-CLOCKWISE |
| 00190707054366 | .012 SHORTY LIGATURE TWISTS |
| 00190707053208 | 3 X 3 DIRECT BOND RETAINER - 30mm |
| 00190707053192 | 3 X 3 DIRECT BOND RETAINER - 28mm |
| 00190707053185 | 3 X 3 DIRECT BOND RETAINER - 26mm |
| 00190707053178 | 3 X 3 DIRECT BOND RETAINER - 24mm |
| 00190707053161 | 3 X 3 DIRECT BOND RETAINER KIT |
| 00190707053154 | .027 TISSUE GUARD -GRAY 10 FT |
| 00190707053147 | .027 TISSUE GUARD- CLEAR 10 FT |
| 00190707053130 | .046 TISSUE GUARD -GRAY 10 FT |
| 00190707053123 | .046 TISSUE GUARD- CLEAR 10 FT |
| 00190707053116 | .018 TISSUE GUARD -GRAY 10 FT |
| 00190707053109 | .018 TISSUE GUARD- CLEAR 10 FT |
| 00190707053093 | .030 ELASTIC TUBE - GRAY 50 FT |
| 00190707053086 | .025 ELASTIC TUBE - GRAY 50 FT |
| 00190707053079 | .030 ELASTIC TUBE - CLEAR 50 FT |
| 00190707053062 | .025 ELASTIC TUBE - CLEAR 50 FT |
| 00190707053055 | .030 ELASTIC THREAD - GRAY 50 FT |
| 00190707053048 | .025 ELASTIC THREAD - GRAY 50 FT |
| 00190707048631 | WELDABLE LINGUAL BUTTON - CURVED |
| 00190707048624 | DIRECT BOND EYELET |
| 00190707046002 | .011 LIGATURE WIRE-1LB SPOOL |
| 00190707045999 | .010 LIGATURE WIRE-1LB SPOOL |
| 00190707045982 | .009 LIGATURE WIRE-1LB SPOOL |
| 00190707045975 | SAFARI NEON ELASTIC MEDIUM 3/8" (4.5oz)-WARTHOG |
| 00190707045968 | SAFARI NEON ELASTIC MEDIUM 5/16" (4.5oz)-GORILLA |
| 00190707045951 | SAFARI NEON ELASTIC MEDIUM 1/4" (4.5oz)-LION |
| 00190707045944 | SAFARI NEON ELASTIC MEDIUM 3/16" (4.5oz)-ZEBRA |
| 00190707045937 | SAFARI NEON ELASTIC MEDIUM 1/8" (4.5oz)- CHIMPANZEE |
| 00190707045760 | SAFE-T-SEPARATORS - SLIM BLUE |
| 00190707045753 | SAFE-T-SEPARATORS - STANDARD PURPLE |
| 00190707045715 | SAFARI AMBER ELASTIC HEAVY 3/8 (6.5oz)-CROCODILE |
| 00190707045708 | SAFARI AMBER ELASTIC MEDIUM 3/8 (4.5oz)-WARTHOG |
| 00190707045692 | SAFARI AMBER ELASTIC LIGHT 3/8 (2.5oz)-VULTURE |
| 00190707045685 | SAFARI AMBER ELASTIC HEAVY 5/16 (6.5oz)-HIPPO |
| 00190707045678 | SAFARI AMBER ELASTIC MEDIUM 5/16 (4.5oz)-GORILLA |
| 00190707045661 | SAFARI AMBER ELASTIC LIGHT 5/16 (2.5oz)-LEOPARD |
| 00190707045654 | SAFARI AMBER ELASTIC HEAVY 1/4 (6.5oz)-RHINO |
| 00190707045647 | SAFARI AMBER ELASTIC MEDIUM 1/4 (4.5oz)-LION |
| 00190707045630 | SAFARI AMBER ELASTIC LIGHT 1/4 (2.5oz)-GAZELLE |
| 00190707045623 | SAFARI AMBER ELASTIC HEAVY 3/16 (6.5oz)-ELEPHANT |
| 00190707045616 | SAFARI AMBER ELASTIC MEDIUM 3/16 (4.5oz)-ZEBRA |
Trademark Results [Ortho Organizers]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORTHO ORGANIZERS 73580959 1486031 Live/Registered |
ORTHO ORGANIZERS, INC. 1986-02-03 |
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