Atmos
Supplies Atmos BRX Thermoforming MATERIAL.040 120MM Circle 100/PK
19manufacturers in China registered for this device type
45catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Zhejiang (6), Guangdong (6), Shanghai (3). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Sezen Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 7 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | Yang Jiao Lang Zin’An Town | Zhejiang | Manufacturer | 39 |
| Hangzhou Wise Medical Device Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 25 |
| Nanchang White Technology Co., Ltd. | Nanchang | Jiangxi | Contract manufacturer | 21 |
| Huizhou Gold Rose Technology Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 19 |
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
| Aidite (Qinhuangdao) Technology Co., Ltd. | Qinhuangdao | Hebei | Repacker / relabeller | 17 |
| Shenzhen Sunmc Dental Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 17 |
| Royal Dental Lab | Shenzhen | Guangdong | Manufacturer | 12 |
| Hubei YJT Intelligent Technology Group Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 12 |
Showing 12 of 19. All 19 manufacturers in China registered for Positioner, Tooth, Preformed
Record
| Listed by | American Orthodontics, United States |
|---|---|
| FDA product code | KMY |
| Device type | Positioner, Tooth, Preformed |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5525 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-02-10 |
| Record revised | 2020-07-23 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 6 to 27 °C; Special storage condition: Keep Away from Light, Keep Dry |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 909-030656BAG | In distribution | |
| 909-030652BAG | In distribution | |
| 909-036814 | In distribution | |
| 909-030663BAG | In distribution | |
| 909-030656 | In distribution | |
| 909-030663 | In distribution | |
| 909-030668 | In distribution | |
| 909-030662BAG | In distribution | |
| 909-030669 | In distribution | |
| 909-030654BAG | In distribution | |
| 909-030669BAG | In distribution | |
| 909-030664BAG | In distribution | |
| 909-030655BAG | In distribution | |
| 909-030654 | In distribution | |
| 909-030661BAG | In distribution | |
| 909-030659BAG | In distribution | |
| 909-030665BAG | In distribution | |
| 909-030658BAG | In distribution | |
| 909-035683BAG | In distribution | |
| 909-030660 | In distribution | |
| 909-030665 | In distribution | |
| 909-030661 | In distribution | |
| 909-030655 | In distribution | |
| 909-030667BAG | In distribution | |
| 909-030664 | In distribution | |
| 909-030662 | In distribution | |
| 909-036815 | In distribution | |
| 909-030659 | In distribution | |
| 909-035681BAG | In distribution | |
| 909-036816 | In distribution | |
| 909-030657 | In distribution | |
| 909-035681 | In distribution | |
| 909-030666 | In distribution | |
| 909-030668BAG | In distribution | |
| 909-030658 | In distribution | |
| 909-030660BAG | In distribution | |
| 909-030653 | In distribution | |
| 909-030652 | In distribution | |
| 909-030666BAG | In distribution | |
| 909-035682BAG | In distribution | |
| 909-035683 | In distribution | |
| 909-030667 | In distribution | |
| 909-030657BAG | In distribution | |
| 909-035682 | In distribution | |
| 909-030653BAG | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Amcop Bioactivator | Micerium SPA | 265 |
| LMDental | LM-Dental | 195 |
| Myobrace® | Myofunctional Research Corp. PTY. Ltd. | 123 |
| Pre-Finisher | TP Orthodontics, Inc. | 120 |
| Drufosoft® | Dreve Dentamid Gmbh | 93 |
| Proform | Keystone Industries | 88 |
| Orthocryl® | Dentaurum GmbH & Co. KG | 65 |
| Duran® | Scheu-Dental Gmbh | 40 |
| Biolon | Dreve Dentamid Gmbh | 38 |
| Positioner, Tooth, Preformed | Dentaurum GmbH & Co. KG | 31 |
| The Trainer System™ | Myofunctional Research Corp. PTY. Ltd. | 30 |
| IPS | KLS-Martin L.P. | 28 |
Showing 12 of 220. All products under Positioner, Tooth, Preformed
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K904128 | 1990-11-09 |
| K891328 | 1989-03-31 |
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.