Robot Point
Small Guide Groove Cutter - RE
7manufacturers in China registered for this device type
122catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (5), Jiangsu (1), Henan (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Huizhou Videya Technology Co., Ltd. | Huizhou | Guangdong | Manufacturer | 18 |
| Shenzhen Superline Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 12 |
| Shenzhen Forever Medical Devices Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 9 |
| Deprag High Tech Materials ( Zhengzhou ) Co., Ltd. | Zhangzhou | Henan | Manufacturer | 6 |
Record
| Listed by | Shofu Dental Corp., United States |
|---|---|
| FDA product code | DZP |
| Device type | Instrument, Diamond, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4535 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2021-02-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0835-1 | In distribution | |
| 883F-1 | In distribution | |
| 0800-1 | In distribution | |
| 0864-1 | In distribution | |
| 883C-1 | In distribution | |
| 0890-1 | In distribution | |
| 835F-1 | In distribution | |
| 0861-1 | In distribution | |
| 0831-1 | In distribution | |
| 0858-1 | In distribution | |
| 0789-1 | In distribution | |
| 0891-1 | In distribution | |
| 895X-1 | In distribution | |
| 0840-1 | In distribution | |
| 0838-1 | In distribution | |
| 874V-1 | In distribution | |
| 898X-1 | In distribution | |
| 895C-1 | In distribution | |
| 832F-1 | In distribution | |
| 893V-1 | In distribution | |
| 840V-1 | In distribution | |
| 0875-1 | In distribution | |
| 892X-1 | In distribution | |
| 875F-1 | In distribution | |
| 0945-1 | In distribution | |
| 0814-1 | In distribution | |
| 0793-1 | In distribution | |
| 883V-1 | In distribution | |
| 0888-1 | In distribution | |
| 0885-1 | In distribution | |
| 850X-1 | In distribution | |
| 842F-1 | In distribution | |
| 880V-1 | In distribution | |
| 848F-1 | In distribution | |
| 0792-1 | In distribution | |
| 0874-1 | In distribution | |
| 0866-1 | In distribution | |
| 0791-1 | In distribution | |
| 0818-1 | In distribution | |
| 0846-1 | In distribution | |
| 0868-1 | In distribution | |
| 840F-1 | In distribution | |
| 0896-1 | In distribution | |
| 836V-1 | In distribution | |
| 0805-1 | In distribution | |
| 0892-1 | In distribution | |
| 0830-1 | In distribution | |
| 0883-1 | In distribution | |
| 0886-1 | In distribution | |
| 0893-1 | In distribution | |
| 899V-1 | In distribution | |
| 0826-1 | In distribution | |
| 0944-1 | In distribution | |
| 789V-1 | In distribution | |
| 843V-1 | In distribution | |
| 0813-1 | In distribution | |
| 0859-1 | In distribution | |
| 0842-1 | In distribution | |
| 835C-1 | In distribution | |
| 840C-1 | In distribution | |
| 791V-1 | In distribution | |
| 0807-1 | In distribution | |
| 0894-1 | In distribution | |
| 0852-1 | In distribution | |
| 793V-1 | In distribution | |
| 0860-1 | In distribution | |
| 847F-1 | In distribution | |
| 0810-1 | In distribution | |
| 0850-1 | In distribution | |
| 0824-1 | In distribution | |
| 839V-1 | In distribution | |
| 0880-1 | In distribution | |
| 0898-1 | In distribution | |
| 0881-1 | In distribution | |
| 0825-1 | In distribution | |
| 0948-1 | In distribution | |
| 883X-1 | In distribution | |
| 790V-1 | In distribution | |
| 850F-1 | In distribution | |
| 832X-1 | In distribution | |
| 0865-1 | In distribution | |
| 0833-1 | In distribution | |
| 0820-1 | In distribution | |
| 0856-1 | In distribution | |
| 0899-1 | In distribution | |
| 845C-1 | In distribution | |
| 876X-1 | In distribution | |
| 0947-1 | In distribution | |
| 833V-1 | In distribution | |
| 845X-1 | In distribution | |
| 0848-1 | In distribution | |
| 825V-1 | In distribution | |
| 0837-1 | In distribution | |
| 0897-1 | In distribution | |
| 826V-1 | In distribution | |
| 0844-1 | In distribution | |
| 0946-1 | In distribution | |
| 792V-1 | In distribution | |
| 0895-1 | In distribution | |
| 0801-1 | In distribution | |
| 0822-1 | In distribution | |
| 0870-1 | In distribution | |
| 817C-1 | In distribution | |
| 0855-1 | In distribution | |
| 841V-1 | In distribution | |
| 0812-1 | In distribution | |
| 840X-1 | In distribution | |
| 0832-1 | In distribution | |
| 835X-1 | In distribution | |
| 0790-1 | In distribution | |
| 0878-1 | In distribution | |
| 0876-1 | In distribution | |
| 846F-1 | In distribution | |
| 0816-1 | In distribution | |
| 0834-1 | In distribution | |
| 0949-1 | In distribution | |
| 820F-1 | In distribution | |
| 0872-1 | In distribution | |
| 0839-1 | In distribution | |
| 0803-1 | In distribution | |
| 0879-1 | In distribution | |
| 0836-1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MDT Diamond Coated Dental Burs | M.D.T. – Micro Diamond Technologies Ltd. | 31,050 |
| MDT Diamond Coated Dental Burs -Sterile | M.D.T. – Micro Diamond Technologies Ltd. | 3,719 |
| FG diamond | DFS-Diamon Gmbh | 2,527 |
| Horico | Hopf, Ringleb & Co. Gmbh & CIE. | 2,320 |
| Two Striper | Abrasive Technology, LLC | 2,294 |
| Sunshine Diamonds | DR. Hopf Gmbh & Co. KG | 2,240 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 2,016 |
| Edenta | Edenta Etablissement | 1,831 |
| Instrument, Diamond, Dental | Hager & Meisinger Gesellschaft mit beschränkter Haftung | 1,827 |
| Jota | Jota AG | 1,615 |
| Komet Dental Diamond Instruments | Gebr. Brasseler Gmbh & Co. KG | 1,610 |
| dental diamond bur | Strauss & Co – Industrial Diamonds Ltd | 1,456 |
Showing 12 of 366. All products under Instrument, Diamond, Dental
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K854347 | 1985-12-27 |
| K833038 | 1983-10-04 |
| K832856 | 1983-10-04 |
| K832855 | 1983-09-29 |
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.