Optiprint I-B-T 385
2 catalogue numbers from 48101, listed by Dentona AG, Germany, under Teeth, Artificial, Backing And Facing. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (3), Anhui (1), Hong Kong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Anqing Clean Dental Instrument Technology Co., Ltd. | Anqing | Anhui | Manufacturer | 50 |
| Improve Co., Limited | Lantau Island | Hong Kong | Contract manufacturer | 16 |
| Royal Dental Lab | Shenzhen | Guangdong | Manufacturer | 12 |
| Linjiang (Holdings) Limited | Shangqiu | Henan | Private-label distributor | 11 |
| Smart Dental CAD Solutions Limited | Zhuhai | Guangdong | Manufacturer | 8 |
| FOO Tian Dental Laboratory | Shenzhen | Guangdong | Manufacturer | 6 |
| Jintaik (Yunnan) Biotech Co., Ltd. | Kunming | Yunnan | Manufacturer | 5 |
| Xiao Fei Dental Manufacture (Chengdu) Co., Ltd. | Chengdu | Sichuan | Remanufacturer | 5 |
| Shanghai dental labs Inc. | Shanghai | Shanghai | Contract manufacturer | 4 |
Record
| Listed by | Dentona AG, Germany |
|---|---|
| FDA product code | ELK |
| Device type | Teeth, Artificial, Backing And Facing |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3910 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-06-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 48101 | In distribution | |
| 48100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| optiprint lumina | Dentona AG | 34 |
| Vertex-Dental BV | Vertex-Dental B.V. | 6 |
| Ceramill | Vertex-Dental B.V. | 3 |
| Isotek, MDC Dental | MDC Dental | 2 |
| Newtek, MDC Dental | MDC Dental | 2 |
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.