IN-Ovation® C
IN-OVATION® C Base Rx 018 U5-5/L3-3 CS-BC HK/IOR
1manufacturer
327catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuxi TP Orthodontics Material Co., Ltd. | Wuxi | Jiangsu | Repacker / relabeller | 9 |
Record
| Listed by | Dentsply Sirona Orthodontics Inc., United States |
|---|---|
| FDA product code | NJM |
| Device type | Bracket, Ceramic, Orthodontic |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5470 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2017-06-26 |
| Record revised | 2024-04-05 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Distribution end date | 2021-02-19 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| H100-131-60 | 5 | Withdrawn | |
| B100-001-10 | 10 | Withdrawn | |
| 100-431-61 | 5 | Withdrawn | |
| 100-211-80 | 5 | Withdrawn | |
| 100-222-08 | 5 | Withdrawn | |
| H100-121-08 | 5 | Withdrawn | |
| H100-232-00 | 5 | Withdrawn | |
| 100-212-80 | 5 | Withdrawn | |
| 100-141-00 | 5 | Withdrawn | |
| 100-222-00 | 5 | Withdrawn | |
| 100-232-61 | 5 | Withdrawn | |
| 100-132-00 | 5 | Withdrawn | |
| H100-132-17 | 5 | Withdrawn | |
| 100-331-61 | 5 | Withdrawn | |
| H100-242-00 | 5 | Withdrawn | |
| H100-331-10 | 5 | Withdrawn | |
| 100-541-80 | 5 | Withdrawn | |
| 100-111-00 | 5 | Withdrawn | |
| 100-241-10 | 5 | Withdrawn | |
| 100-210-00 | 5 | Withdrawn | |
| K100-531-61 | 16 | Withdrawn | |
| 100-332-17 | 5 | Withdrawn | |
| H100-121-00 | 5 | Withdrawn | |
| K100-331-10 | 12 | Withdrawn | |
| B100-012-82 | 16 | Withdrawn | |
| H100-231-10 | 5 | Withdrawn | |
| H100-551-80 | 5 | Withdrawn | |
| H100-122-08 | 5 | Withdrawn | |
| H100-311-00 | 5 | Withdrawn | |
| H100-121-60 | 5 | Withdrawn | |
| B100-011-81 | 16 | Withdrawn | |
| H100-331-82 | 5 | Withdrawn | |
| H100-221-60 | 5 | Withdrawn | |
| 100-231-00 | 5 | Withdrawn | |
| 100-232-82 | 5 | Withdrawn | |
| H100-141-60 | 5 | Withdrawn | |
| H100-332-00 | 5 | Withdrawn | |
| H100-541-07 | 5 | Withdrawn | |
| 100-332-10 | 5 | Withdrawn | |
| H100-132-18 | 5 | Withdrawn | |
| H100-110-00 | 5 | Withdrawn | |
| H100-431-00 | 5 | Withdrawn | |
| K100-152-10 | 10 | Withdrawn | |
| H100-222-08 | 5 | Withdrawn | |
| 100-132-81 | 5 | Withdrawn | |
| 100-431-10 | 5 | Withdrawn | |
| B100-002-80 | 10 | Withdrawn | |
| 100-231-18 | 5 | Withdrawn | |
| H100-141-61 | 5 | Withdrawn | |
| K100-532-61 | 16 | Withdrawn | |
| H100-241-10 | 5 | Withdrawn | |
| 100-232-00 | 5 | Withdrawn | |
| 100-611-60 | 5 | Withdrawn | |
| 100-432-61 | 5 | Withdrawn | |
| 100-232-60 | 5 | Withdrawn | |
| 100-411-00 | 5 | Withdrawn | |
| H100-222-00 | 5 | Withdrawn | |
| H100-111-08 | 5 | Withdrawn | |
| 100-241-60 | 5 | Withdrawn | |
| H100-131-17 | 5 | Withdrawn | |
| H100-120-00 | 5 | Withdrawn | |
| H100-122-07 | 5 | Withdrawn | |
| H100-431-17 | 5 | Withdrawn | |
| H100-211-07 | 5 | Withdrawn | |
| H100-611-60 | 5 | Withdrawn | |
| K100-151-00 | 10 | Withdrawn | |
| K100-152-81 | 10 | Withdrawn | |
| H100-131-18 | 5 | Withdrawn | |
| H100-241-00 | 5 | Withdrawn | |
| K100-151-11 | 10 | Withdrawn | |
| K100-551-81 | 16 | Withdrawn | |
| H100-232-82 | 5 | Withdrawn | |
| K100-332-60 | 12 | Withdrawn | |
| H100-211-80 | 5 | Withdrawn | |
| 100-232-18 | 5 | Withdrawn | |
| H100-332-10 | 5 | Withdrawn | |
| H100-212-00 | 5 | Withdrawn | |
| 100-141-10 | 5 | Withdrawn | |
| 100-231-10 | 5 | Withdrawn | |
| 100-132-61 | 5 | Withdrawn | |
| H100-241-60 | 5 | Withdrawn | |
| 100-331-00 | 5 | Withdrawn | |
| 100-551-80 | 5 | Withdrawn | |
| H100-232-18 | 5 | Withdrawn | |
| B100-001-81 | 10 | Withdrawn | |
| H100-121-80 | 5 | Withdrawn | |
| 100-331-10 | 5 | Withdrawn | |
| H100-231-17 | 5 | Withdrawn | |
| K100-532-60 | 16 | Withdrawn | |
| 100-431-00 | 5 | Withdrawn | |
| 100-232-81 | 5 | Withdrawn | |
| 100-432-82 | 5 | Withdrawn | |
| B100-012-81 | 16 | Withdrawn | |
| H100-111-80 | 5 | Withdrawn | |
| 100-332-81 | 5 | Withdrawn | |
| H100-411-00 | 5 | Withdrawn | |
| 100-541-07 | 5 | Withdrawn | |
| 100-221-08 | 5 | Withdrawn | |
| H100-332-81 | 5 | Withdrawn | |
| 100-431-17 | 5 | Withdrawn | |
| K100-151-80 | 10 | Withdrawn | |
| K100-152-61 | 10 | Withdrawn | |
| H100-132-60 | 5 | Withdrawn | |
| H100-141-17 | 5 | Withdrawn | |
| H100-131-10 | 5 | Withdrawn | |
| H100-232-10 | 5 | Withdrawn | |
| H100-211-00 | 5 | Withdrawn | |
| 100-332-82 | 5 | Withdrawn | |
| 100-131-61 | 5 | Withdrawn | |
| H100-221-07 | 5 | Withdrawn | |
| 100-211-08 | 5 | Withdrawn | |
| H100-331-81 | 5 | Withdrawn | |
| 100-122-60 | 5 | Withdrawn | |
| H100-242-60 | 5 | Withdrawn | |
| 100-121-60 | 5 | Withdrawn | |
| H100-131-00 | 5 | Withdrawn | |
| H100-111-07 | 5 | Withdrawn | |
| 100-110-00 | 5 | Withdrawn | |
| K100-552-81 | 16 | Withdrawn | |
| H100-310-00 | 5 | Withdrawn | |
| H100-552-80 | 5 | Withdrawn | |
| H100-232-81 | 5 | Withdrawn | |
| H100-142-10 | 5 | Withdrawn | |
| K100-132-10 | 6 | Withdrawn | |
| 100-242-60 | 5 | Withdrawn | |
| H100-112-08 | 5 | Withdrawn | |
| H100-332-17 | 5 | Withdrawn | |
| 100-122-08 | 5 | Withdrawn | |
| H100-142-00 | 5 | Withdrawn | |
| K100-532-10 | 16 | Withdrawn | |
| 100-241-00 | 5 | Withdrawn | |
| H100-241-17 | 5 | Withdrawn | |
| 100-241-61 | 5 | Withdrawn | |
| 100-131-18 | 5 | Withdrawn | |
| H100-241-61 | 5 | Withdrawn | |
| 100-231-17 | 5 | Withdrawn | |
| B100-001-11 | 10 | Withdrawn | |
| H100-432-60 | 5 | Withdrawn | |
| K100-332-10 | 12 | Withdrawn | |
| H100-332-61 | 5 | Withdrawn | |
| H100-122-80 | 5 | Withdrawn | |
| H100-231-81 | 5 | Withdrawn | |
| 100-141-17 | 5 | Withdrawn | |
| 100-432-60 | 5 | Withdrawn | |
| 100-331-82 | 5 | Withdrawn | |
| 100-142-61 | 5 | Withdrawn | |
| H100-132-61 | 5 | Withdrawn | |
| 100-112-00 | 5 | Withdrawn | |
| 100-111-80 | 5 | Withdrawn | |
| H100-231-00 | 5 | Withdrawn | |
| K100-551-82 | 16 | Withdrawn | |
| H100-132-00 | 5 | Withdrawn | |
| H100-221-08 | 5 | Withdrawn | |
| 100-212-08 | 5 | Withdrawn | |
| H100-432-10 | 5 | Withdrawn | |
| 100-332-00 | 5 | Withdrawn | |
| H100-611-80 | 5 | Withdrawn | |
| H100-242-17 | 5 | Withdrawn | |
| B100-002-10 | 10 | Withdrawn | |
| H100-432-61 | 5 | Withdrawn | |
| H100-431-81 | 5 | Withdrawn | |
| H100-121-07 | 5 | Withdrawn | |
| H100-611-07 | 5 | Withdrawn | |
| H100-431-61 | 5 | Withdrawn | |
| H100-431-60 | 5 | Withdrawn | |
| 100-231-61 | 5 | Withdrawn | |
| H100-112-00 | 5 | Withdrawn | |
| B100-011-11 | 16 | Withdrawn | |
| H100-112-80 | 5 | Withdrawn | |
| 100-221-00 | 5 | Withdrawn | |
| 100-611-07 | 5 | Withdrawn | |
| H100-432-82 | 5 | Withdrawn | |
| H100-231-61 | 5 | Withdrawn | |
| H100-612-08 | 5 | Withdrawn | |
| B100-001-80 | 10 | Withdrawn | |
| H100-541-80 | 5 | Withdrawn | |
| 100-212-00 | 5 | Withdrawn | |
| 100-552-81 | 5 | Withdrawn | |
| H100-112-60 | 5 | Withdrawn | |
| H100-211-60 | 5 | Withdrawn | |
| H100-232-60 | 5 | Withdrawn | |
| 100-242-00 | 5 | Withdrawn | |
| 100-211-07 | 5 | Withdrawn | |
| B100-012-11 | 16 | Withdrawn | |
| 100-231-81 | 5 | Withdrawn | |
| H100-412-00 | 5 | Withdrawn | |
| K100-131-61 | 6 | Withdrawn | |
| H100-431-82 | 5 | Withdrawn | |
| K100-552-82 | 16 | Withdrawn | |
| H100-132-10 | 5 | Withdrawn | |
| 100-120-00 | 5 | Withdrawn | |
| 100-242-10 | 5 | Withdrawn | |
| 100-212-60 | 5 | Withdrawn | |
| 100-221-60 | 5 | Withdrawn | |
| 100-111-07 | 5 | Withdrawn | |
| H100-210-00 | 5 | Withdrawn | |
| H100-612-07 | 5 | Withdrawn | |
| H100-132-82 | 5 | Withdrawn | |
| H100-131-61 | 5 | Withdrawn | |
| H100-231-82 | 5 | Withdrawn | |
| 100-111-08 | 5 | Withdrawn | |
| 100-211-60 | 5 | Withdrawn | |
| H100-312-00 | 5 | Withdrawn | |
| 100-112-60 | 5 | Withdrawn | |
| 100-141-61 | 5 | Withdrawn | |
| 100-221-80 | 5 | Withdrawn | |
| H100-111-60 | 5 | Withdrawn | |
| 100-331-60 | 5 | Withdrawn | |
| B100-012-10 | 16 | Withdrawn | |
| H100-141-00 | 5 | Withdrawn | |
| 100-122-00 | 5 | Withdrawn | |
| H100-142-61 | 5 | Withdrawn | |
| 100-431-82 | 5 | Withdrawn | |
| 100-111-60 | 5 | Withdrawn | |
| 100-132-10 | 5 | Withdrawn | |
| H100-221-00 | 5 | Withdrawn | |
| H100-410-00 | 5 | Withdrawn | |
| 100-222-80 | 5 | Withdrawn | |
| H100-542-07 | 5 | Withdrawn | |
| K100-531-00 | 16 | Withdrawn | |
| 100-331-81 | 5 | Withdrawn | |
| H100-111-00 | 5 | Withdrawn | |
| 100-121-07 | 5 | Withdrawn | |
| 100-121-00 | 5 | Withdrawn | |
| H100-222-60 | 5 | Withdrawn | |
| K100-532-11 | 16 | Withdrawn | |
| H100-112-07 | 5 | Withdrawn | |
| H100-332-60 | 5 | Withdrawn | |
| 100-611-80 | 5 | Withdrawn | |
| H100-131-81 | 5 | Withdrawn | |
| K100-331-60 | 12 | Withdrawn | |
| 100-131-81 | 5 | Withdrawn | |
| B100-011-10 | 16 | Withdrawn | |
| K100-152-00 | 10 | Withdrawn | |
| K100-531-10 | 16 | Withdrawn | |
| 100-121-80 | 5 | Withdrawn | |
| 100-121-08 | 5 | Withdrawn | |
| 100-231-82 | 5 | Withdrawn | |
| 100-112-80 | 5 | Withdrawn | |
| 100-122-80 | 5 | Withdrawn | |
| H100-432-81 | 5 | Withdrawn | |
| 100-232-10 | 5 | Withdrawn | |
| H100-232-61 | 5 | Withdrawn | |
| H100-332-82 | 5 | Withdrawn | |
| H100-122-60 | 5 | Withdrawn | |
| H100-432-17 | 5 | Withdrawn | |
| 100-112-08 | 5 | Withdrawn | |
| 100-542-80 | 5 | Withdrawn | |
| H100-231-60 | 5 | Withdrawn | |
| 100-142-00 | 5 | Withdrawn |
Showing 250 of 300 catalogue numbers.
Same Product Code
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|---|---|---|
| QuicKlear® | Forestadent Bernhard Förster GmbH | 841 |
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| Experience | GC Orthodontics America Inc. | 500 |
| TruKlear | Forestadent Bernhard Förster GmbH | 401 |
| Chic | GC Orthodontics America Inc. | 348 |
| Bracket, Ceramic, Orthodontic | Forestadent Bernhard Förster GmbH | 342 |
| Intrigue | Lancer Orthodontics, Inc. | 253 |
| Empower Clear | American Orthodontics | 250 |
| Empower Clear Bracket | American Orthodontics | 250 |
| InVu Ceramic Brackets | TP Orthodontics, Inc. | 226 |
| RadiancePlus | American Orthodontics | 179 |
| InVu Readi-Base Brackets | TP Orthodontics, Inc. | 173 |
Showing 12 of 399. All products under Bracket, Ceramic, Orthodontic
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.