Encore!
Encore! Ceramic 022 LR3 Hk Roth Rx -11° Tor. +5° Ang.(10PK)
1manufacturer
93catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Ortho Technology, Inc., United States |
|---|---|
| FDA product code | NJM |
| Device type | Bracket, Ceramic, Orthodontic |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5470 |
| 510(k) | K922499 |
| Record published | 2016-09-24 |
| Record revised | 2024-12-31 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2024-09-18 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MC-851 | In distribution | |
| MC-864 | In distribution | |
| MCM22-100 | In distribution | |
| MC-873 | In distribution | |
| MC-861 | In distribution | |
| MC-830 | In distribution | |
| MC-862 | In distribution | |
| MC-722 | In distribution | |
| MC-712 | In distribution | |
| MC-762 | In distribution | |
| MC-802 | In distribution | |
| MC-764 | In distribution | |
| MC-774 | In distribution | |
| MC-772 | In distribution | |
| MC-763 | In distribution | |
| MC-874 | In distribution | |
| MC-751 | In distribution | |
| MC-801 | In distribution | |
| MC-872 | In distribution | |
| MC-871 | In distribution | |
| MC-741 | In distribution | |
| MC-812 | In distribution | |
| MC-811 | In distribution | |
| MCM18-1000 | In distribution | |
| MC-863 | In distribution | |
| MC-752 | In distribution | |
| MC-730 | In distribution | |
| MC-841 | In distribution | |
| MCM18-100 | In distribution | |
| MC-702 | In distribution | |
| MC-711 | In distribution | |
| MC-001 | In distribution | |
| MC-731 | In distribution | |
| MC-761 | In distribution | |
| MC-821 | In distribution | |
| MC-831 | In distribution | |
| MC-721 | In distribution | |
| MC-771 | In distribution | |
| MC-822 | In distribution | |
| MCM22-1000 | In distribution | |
| MC-852 | In distribution | |
| MC-070 | Withdrawn | |
| MC18360 | Withdrawn | |
| MC-112 | Withdrawn | |
| MC-151 | Withdrawn | |
| MC22360 | Withdrawn | |
| MC-031 | Withdrawn | |
| MC-052 | Withdrawn | |
| MC-701 | Withdrawn | |
| MC-161 | Withdrawn | |
| MC-002 | Withdrawn | |
| MC-061 | Withdrawn | |
| MC-041 | Withdrawn | |
| MC18320 | Withdrawn | |
| MCM18-1300 | Withdrawn | |
| MC-071 | Withdrawn | |
| MCM22-1345 | Withdrawn | |
| MCM18320 | Withdrawn | |
| MCM22320 | Withdrawn | |
| MC-170 | Withdrawn | |
| MCM22360 | Withdrawn | |
| MCM18-300 | Withdrawn | |
| MC-102 | Withdrawn | |
| MC-160 | Withdrawn | |
| MCM22-1300 | Withdrawn | |
| MCM18360 | Withdrawn | |
| MC-122 | Withdrawn | |
| MC22-1300 | Withdrawn | |
| MC22320 | Withdrawn | |
| MC-141 | Withdrawn | |
| MCM22370 | Withdrawn | |
| MC-121 | Withdrawn | |
| MCM22-300 | Withdrawn | |
| MC18370 | Withdrawn | |
| MC-030 | Withdrawn | |
| MC-051 | Withdrawn | |
| MC18-1300 | Withdrawn | |
| MC-022 | Withdrawn | |
| MC-101 | Withdrawn | |
| MC18-1345 | Withdrawn | |
| MC-131 | Withdrawn | |
| MC-152 | Withdrawn | |
| MC-060 | Withdrawn | |
| MC-021 | Withdrawn | |
| MC-011 | Withdrawn | |
| MC-130 | Withdrawn | |
| MCM18-1345 | Withdrawn | |
| MC-171 | Withdrawn | |
| MC-773 | Withdrawn | |
| MC-111 | Withdrawn | |
| MC22-1345 | Withdrawn | |
| MC-012 | Withdrawn | |
| MC22370 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| QuicKlear® | Forestadent Bernhard Förster GmbH | 841 |
| Bracket, Ceramic, Orthodontic | Flexmedics | 600 |
| 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 |
| IN-Ovation® C | Dentsply Sirona Orthodontics Inc. | 327 |
| 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 |
Showing 12 of 399. All products under Bracket, Ceramic, Orthodontic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K112707 | 2012-01-13 |
| K073045 | 2007-12-18 |
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.