Redline
- Primary DI
- 00810002220135
- Brand
- Redline
- Company
- JOHN'S DENTAL LABORATORY INC
- Model
- 3014680794
- Device description
- Orthodontic plastic bracket. The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion. The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion. A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system to correct malocclusions (e.g., underbites, overbites, cross bites, open bites, crooked teeth) and/or other cosmetic and/or structural flaws of teeth and/or jaws. Also described as sequential or successive, the device is custom-made based on an oral impression, self-removable, and is typically made of clear/transparent synthetic polymers (e.g., a thermoformed polycarbonate); a post-treatment orthodontic retainer/positioner may be included with the device. This is a reusable device.
- Published
- 2022-09-12
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
Product Codes#
| Code | Name |
|---|---|
| NXC | Aligner, Sequential |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| NXC | Aligner, Sequential | Dental | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K213297 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00810002220135 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00810002220135 | 00810002220135 | 810002220135 | 0810002220135 |
GMDN Terms#
| Term | Definition |
|---|---|
| Orthodontic progressive aligner | A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system to correct malocclusions (e.g., underbites, overbites, cross bites, open bites, crooked teeth) and/or other cosmetic and/or structural flaws of teeth and/or jaws. Also described as sequential or successive, the device is custom-made based on an oral impression, self-removable, and is typically made of clear/transparent synthetic polymers (e.g., a thermoformed polycarbonate); a post-treatment orthodontic retainer/positioner may be included with the device. This is a reusable device. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 016649253
- Device count
- 1
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00810002220104 | Abutment/Implant | 3014680794 | 2020-11-18 | |
| 00810002220272 | Herbst | 3014680794 | 2023-04-05 | |
| 00810002220258 | The Silencer | 3014680794 | 2023-04-03 | |
| 00810002220265 | NAPA (Nocturnal Airway Patency Appliance) | 3014680794 | 2023-04-03 | |
| 00810002220241 | The Luco Hybrid OSA Appliance | 3014680794 | 2023-03-28 | |
| 00810002220234 | Vivos mRNA | 3014680794 | 2023-03-28 | |
| 00810002220166 | Vivos Dorsal mRNA | 3014680794 | 2023-02-14 | |
| 00810002220159 | Vivos DNA-Lower | 3014680794 | 2022-06-13 | |
| 00810002220111 | mmRNA appliance | 3014680794 | 2022-02-04 | |
| 00810002220012 | Vivos DNA | 3014680794 | 2020-09-08 | |
| 00810002220173 | KeyPrint KeySplint Soft | 3014680794 | 2023-04-04 | |
| 00810002220128 | Digital Denture | 3014680794 | 2020-11-25 | |
| 00810002220098 | Herbst | 3014680794 | 2020-09-23 | |
| 00810002220142 | Vivos mmRNA appliance | 3014680794 | 2023-03-28 | |
| 00810002220210 | OASYS (Oral/Nasal Airway System) | 3014680794 | 2023-03-28 | |
| 00810002220203 | EMA (Elastic Mandibular Advancement appliance) | 3014680794 | 2023-03-27 | |
| 00810002220043 | Silencer | 3014680794 | 2020-09-23 | |
| 00810002220081 | NAPA (Nocturnal Airway Patency Appliance) | 3014680794 | 2020-09-23 | |
| 00810002220050 | TAP (Thornton Adjustable Positioner) | 3014680794 | 2020-09-23 | |
| 00810002220067 | TAP (Thornton Adjustable Positioner) 3 | 3014680794 | 2020-09-23 |
Other Devices Sharing Product Codes#
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|---|---|---|---|---|
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| 08800142100963 | TERA HARZ CLEAR | Graphy Inc. | NXC | 2026-08-21 |
| 08800142100987 | TERA HARZ CLEAR | Graphy Inc. | NXC | 2026-08-21 |
| 08800142100994 | TERA HARZ CLEAR | Graphy Inc. | NXC | 2026-08-21 |
| 00850004223253 | CandidPro | CANDID CARE CO. | NXC | 2026-07-27 |
| 00850004223260 | CandidPro | CANDID CARE CO. | NXC | 2026-07-27 |
| 00850004223314 | ProMonitoring | CANDID CARE CO. | NXC | 2026-07-27 |
| 00850004223352 | ProMonitoring | CANDID CARE CO. | NXC | 2026-07-27 |
| 00850004223383 | Oliv | CANDID CARE CO. | NXC | 2026-07-27 |
| 00850004223390 | Oliv | CANDID CARE CO. | NXC | 2026-07-27 |
| 00850004223550 | CandidPro | CANDID CARE CO. | NXC | 2026-07-27 |
| 00856379007313 | SureSmile® | ORAMETRIX, INC. | NXC | 2026-05-20 |
| D77595102 | Smart Moves Complete Phase 1 Trays | Great Lakes Dental Technologies, Ltd. | NXC | 2026-05-07 |
| D775AASS0 | Super Spring Aligner | Great Lakes Dental Technologies, Ltd. | NXC | 2026-05-07 |
| D775ABLR0 | Bloore Removable Aligner | Great Lakes Dental Technologies, Ltd. | NXC | 2026-05-07 |
| D775AII0 | Invisible Inman Aligner | Great Lakes Dental Technologies, Ltd. | NXC | 2026-05-07 |
| D775ALIA0 | Lower Inman Aligner | Great Lakes Dental Technologies, Ltd. | NXC | 2026-05-07 |
| D775ALIAW0 | Lower Inman Aligner 'Wireless' | Great Lakes Dental Technologies, Ltd. | NXC | 2026-05-07 |
| 06956748700198 | Angel Aligner | Wuxi EA Medical Instruments Technologies Limited. | NXC | 2026-05-06 |
| 00197998216398 | Clarity™ | Solventum Orthodontics Corporation | NXC | 2026-04-25 |
| 00197998216428 | Clarity™ | Solventum Orthodontics Corporation | NXC | 2026-04-25 |
| 00197998216435 | Clarity™ | Solventum Orthodontics Corporation | NXC | 2026-04-25 |
| 00197998216480 | Clarity™ | Solventum Orthodontics Corporation | NXC | 2026-04-25 |
| 00197998216527 | Clarity™ | Solventum Orthodontics Corporation | NXC | 2026-04-25 |
| 00197998216534 | Clarity™ | Solventum Orthodontics Corporation | NXC | 2026-04-25 |
| 00197998216572 | Clarity™ | Solventum Orthodontics Corporation | NXC | 2026-04-25 |
| 00197998216596 | Clarity™ | Solventum Orthodontics Corporation | NXC | 2026-04-25 |
| 00197998216657 | Clarity™ | Solventum Orthodontics Corporation | NXC | 2026-04-25 |
| 00197998216664 | Clarity™ | Solventum Orthodontics Corporation | NXC | 2026-04-25 |