Handy IIM
Handy IIM ART W/O PL
7manufacturers in China registered for this device type
6catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (5), Jiangsu (1), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Shanghai Alwings Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 39 |
| Dongguan Yilong Medical Supplies Co.. Ltd. | Dongguan | Guangdong | Contract manufacturer | 8 |
| Topway Dental Laboratory Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
Record
| Listed by | Shofu Dental Corp., United States |
|---|---|
| FDA product code | EJP |
| Device type | Articulators |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3150 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2021-02-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5073 | In distribution | |
| 5071 | In distribution | |
| 5070 | In distribution | |
| 5074 | In distribution | |
| 5076 | In distribution | |
| 5075 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hanau modular Articulator | Whip-MIX Corp. | 5 |
| W.O.W.™ | Premier Dental Products Co. | 4 |
| Denar Mark 320 Articulator | Whip-MIX Corp. | 2 |
| Denar Mark 310 Articulator | Whip-MIX Corp. | 2 |
| 2240 Q Articulator | Whip-MIX Corp. | 2 |
| Denar Mark 330 Articulator | Whip-MIX Corp. | 2 |
| 4641 Articulator | Whip-MIX Corp. | 1 |
| Arcus | Kavo Dental Gmbh | 1 |
| Hanau-Mate Non-Adjustable Articulator | Whip-MIX Corp. | 1 |
| Hanau Wide-Vue Articulator | Whip-MIX Corp. | 1 |
| D5A Fully-Adjustable Articulator | Whip-MIX Corp. | 1 |
| Lab Scanner | 3Shape A/S | 1 |
Showing 12 of 34. All products under Articulators
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K833039 | 1983-10-04 |
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.