Duo: PCH®
DUO PCH LTRL M 4pc #23&26 RFL
3manufacturers in China registered for this device type
29catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (1), Sichuan (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Jiahong Dental Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Xiao Fei Dental Manufacture (Chengdu) Co., Ltd. | Chengdu | Sichuan | Remanufacturer | 5 |
| Hangzhou Thales Medtech Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 3 |
Record
| Listed by | DEN-MAT Holdings, LLC, United States |
|---|---|
| FDA product code | ELL |
| Device type | Teeth, Porcelain |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3920 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K895269 |
| Record published | 2016-09-24 |
| Record revised | 2021-02-05 (version 4) |
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, expiry date |
| Storage | Handling environment temperature 33 to 75 °F; Storage environment temperature 33 to 75 °F; Special storage condition: Do not expose to direct sunlight; Special storage condition: Do not freeze |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 032912350 | 4 | In distribution | |
| 032912980 | 4 | In distribution | |
| 032913130 | 4 | In distribution | |
| 032913180 | 4 | In distribution | |
| 032912970 | 4 | In distribution | |
| 032912560 | 4 | In distribution | |
| 032912420 | 4 | In distribution | |
| 032913110 | 4 | In distribution | |
| 032913070 | 4 | In distribution | |
| 032913060 | 4 | In distribution | |
| 032912700 | 4 | In distribution | |
| 032912490 | 4 | In distribution | |
| 032912770 | 4 | In distribution | |
| 032913100 | 4 | In distribution | |
| 032913120 | 4 | In distribution | |
| 032913050 | 4 | In distribution | |
| 032912630 | 4 | In distribution | |
| 032913160 | 4 | In distribution | |
| 032913090 | 4 | In distribution | |
| 032912200 | 28 | In distribution | |
| 032913010 | 4 | In distribution | |
| 032913150 | 4 | In distribution | |
| 032913080 | 4 | In distribution | |
| 032913140 | 4 | In distribution | |
| 032913040 | 4 | In distribution | |
| 032913030 | 4 | In distribution | |
| 032913020 | 4 | In distribution | |
| 032912990 | 4 | In distribution | |
| 032913170 | 4 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bioform® VF Porcelain Anteriors | Dentsply LLC | 1,050 |
| Bioblend® Porcelain Anteriors | Dentsply LLC | 696 |
| New Hue® VF Porcelain Anteriors | Dentsply LLC | 240 |
| Physioset CT | Candulor, AG | 236 |
| Bioform® VF 33 Deg. Porcelain Posteriors | Dentsply LLC | 182 |
| Bioform® VF 20 Deg. Porcelain Posteriors | Dentsply LLC | 144 |
| NobelProcera® | Nobel Biocare AB | 112 |
| Bioform® VF Rational Porcelain Posts | Dentsply LLC | 84 |
| Bonartic CT | Candulor, AG | 80 |
| Condyloform CT | Candulor, AG | 71 |
| Bioform® VF Functional Porcelain Posts | Dentsply LLC | 56 |
| Vivid ZirDisc Wieland System | Pearson Dental Supplies, Inc. | 27 |
Showing 12 of 25. All products under Teeth, Porcelain
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K895269 | 1990-02-22 |
| K875351 | 1988-03-18 |
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.