Bioform® VF Porcelain Anteriors
1,050 catalogue numbers from B55 L K1, listed by Dentsply LLC, United States, under Teeth, Porcelain. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1,050catalogue numbers in this listing
5510(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 | Dentsply LLC, United States |
|---|---|
| FDA product code | ELL |
| Device type | Teeth, Porcelain |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3920 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-10-10 |
| Record revised | 2022-05-24 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number |
| Distribution end date | 2022-06-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B55 L K1 | Withdrawn | |
| B62 L D | Withdrawn | |
| B69 U 32E | Withdrawn | |
| B67 U 22G | Withdrawn | |
| B91 U 44F | Withdrawn | |
| B67 U 36F | Withdrawn | |
| B52 U 42D | Withdrawn | |
| B77 U 75G | Withdrawn | |
| B95 L X | Withdrawn | |
| B62 U 13E | Withdrawn | |
| B59 U 44F | Withdrawn | |
| B77 U 62D | Withdrawn | |
| B95 U 25G | Withdrawn | |
| B51 U 46E | Withdrawn | |
| B95 L W | Withdrawn | |
| B59 L S | Withdrawn | |
| B91 L W | Withdrawn | |
| B59 U 45F | Withdrawn | |
| B65 U 42FS | Withdrawn | |
| B77 U 24F | Withdrawn | |
| B91 L L | Withdrawn | |
| B81 U 12ES | Withdrawn | |
| B52 U 45F | Withdrawn | |
| B62 U 62D | Withdrawn | |
| B65 U 54F | Withdrawn | |
| B94 U 21J | Withdrawn | |
| B62 L V | Withdrawn | |
| B55 L Z | Withdrawn | |
| B52 L U | Withdrawn | |
| B81 U 45HS | Withdrawn | |
| B77 U 51F | Withdrawn | |
| B94 U 52C | Withdrawn | |
| B81 U 74E | Withdrawn | |
| B59 L R | Withdrawn | |
| B51 U 13D | Withdrawn | |
| B69 L O | Withdrawn | |
| B66 U 12G | Withdrawn | |
| B59 U 51F | Withdrawn | |
| B66 U 46E | Withdrawn | |
| B77 U 55F | Withdrawn | |
| B52 L N | Withdrawn | |
| B69 L H | Withdrawn | |
| B81 U 64F | Withdrawn | |
| B59 L W | Withdrawn | |
| B65 U 75E | Withdrawn | |
| B66 L C | Withdrawn | |
| B69 U 76G | Withdrawn | |
| B52 U 12F | Withdrawn | |
| B51 U 62E | Withdrawn | |
| B66 L Z | Withdrawn | |
| B91 U 74H | Withdrawn | |
| B65 L K1 | Withdrawn | |
| B69 U 12F | Withdrawn | |
| B69 L T | Withdrawn | |
| B95 U 51F | Withdrawn | |
| B81 U 13D | Withdrawn | |
| B67 L L | Withdrawn | |
| B59 U 65G | Withdrawn | |
| B67 L P | Withdrawn | |
| B66 U 43D | Withdrawn | |
| B52 U 21D | Withdrawn | |
| B55 L O | Withdrawn | |
| B51 U 44E | Withdrawn | |
| B65 L Y | Withdrawn | |
| B91 L U | Withdrawn | |
| B67 U 74E | Withdrawn | |
| B69 U 44F | Withdrawn | |
| B52 L Y | Withdrawn | |
| B95 U 43D | Withdrawn | |
| B81 U 22G | Withdrawn | |
| B66 U 36F | Withdrawn | |
| B67 U 25G | Withdrawn | |
| B77 U 21J | Withdrawn | |
| B52 U 21J | Withdrawn | |
| B66 U 42FS | Withdrawn | |
| B52 L P | Withdrawn | |
| B69 L D | Withdrawn | |
| B77 L E | Withdrawn | |
| B52 U 75E | Withdrawn | |
| B62 U 42FS | Withdrawn | |
| B94 U 12E | Withdrawn | |
| B91 U 12E | Withdrawn | |
| B77 U 32E | Withdrawn | |
| B67 U 45H | Withdrawn | |
| B52 U 31F | Withdrawn | |
| B59 U 74H | Withdrawn | |
| B52 U 62E | Withdrawn | |
| B52 U 44F | Withdrawn | |
| B62 L J | Withdrawn | |
| B65 U 76G | Withdrawn | |
| B62 U 12E | Withdrawn | |
| B77 U 42D | Withdrawn | |
| B62 U 74E | Withdrawn | |
| B55 U 56G | Withdrawn | |
| B51 L M | Withdrawn | |
| B51 U 11H | Withdrawn | |
| B67 U 42FS | Withdrawn | |
| B59 L G | Withdrawn | |
| B94 U 42D | Withdrawn | |
| B69 U 35E | Withdrawn | |
| B66 L F | Withdrawn | |
| B69 U 24F | Withdrawn | |
| B62 U 42D | Withdrawn | |
| B62 U 54F | Withdrawn | |
| B52 U 35E | Withdrawn | |
| B91 U 21D | Withdrawn | |
| B91 U 65G | Withdrawn | |
| B52 U 21F | Withdrawn | |
| B59 U 56G | Withdrawn | |
| B51 L T | Withdrawn | |
| B77 U 12E | Withdrawn | |
| B91 U 62D | Withdrawn | |
| B66 U 75G | Withdrawn | |
| B67 U 56G | Withdrawn | |
| B65 U 11H | Withdrawn | |
| B65 U 31F | Withdrawn | |
| B91 U 42D | Withdrawn | |
| B65 L K | Withdrawn | |
| B52 L L | Withdrawn | |
| B95 U 42D | Withdrawn | |
| B67 U 62G | Withdrawn | |
| B77 L J | Withdrawn | |
| B67 U 24F | Withdrawn | |
| B69 U 75E | Withdrawn | |
| B95 U 13E | Withdrawn | |
| B66 U 22E | Withdrawn | |
| B91 L C | Withdrawn | |
| B94 U 64F | Withdrawn | |
| B62 U 52C | Withdrawn | |
| B66 L T | Withdrawn | |
| B62 L T | Withdrawn | |
| B67 L S | Withdrawn | |
| B69 U 21F | Withdrawn | |
| B67 L Y | Withdrawn | |
| B91 L K1 | Withdrawn | |
| B59 U 11H | Withdrawn | |
| B65 U 25G | Withdrawn | |
| B67 L W | Withdrawn | |
| B65 U 74H | Withdrawn | |
| B65 U 62G | Withdrawn | |
| B66 U 42D | Withdrawn | |
| B65 U 21F | Withdrawn | |
| B52 U 44E | Withdrawn | |
| B69 L P | Withdrawn | |
| B81 L L | Withdrawn | |
| B65 L P | Withdrawn | |
| B81 L R | Withdrawn | |
| B95 U 31F | Withdrawn | |
| B91 L J | Withdrawn | |
| B55 U 46E | Withdrawn | |
| B62 U 75E | Withdrawn | |
| B62 L K | Withdrawn | |
| B52 U 76G | Withdrawn | |
| B94 U 44F | Withdrawn | |
| B51 U 42FS | Withdrawn | |
| B52 L E | Withdrawn | |
| B91 U 75E | Withdrawn | |
| B95 U 64F | Withdrawn | |
| B59 U 12ES | Withdrawn | |
| B59 U 31FS | Withdrawn | |
| B81 U 62G | Withdrawn | |
| B55 U 74H | Withdrawn | |
| B52 U 42F | Withdrawn | |
| B59 L D | Withdrawn | |
| B52 U 52C | Withdrawn | |
| B52 U 43D | Withdrawn | |
| B95 L C | Withdrawn | |
| B95 U 12G | Withdrawn | |
| B95 U 22E | Withdrawn | |
| B51 U 65H | Withdrawn | |
| B52 U 22G | Withdrawn | |
| B67 L N | Withdrawn | |
| B95 U 44E | Withdrawn | |
| B94 U 22E | Withdrawn | |
| B51 L R | Withdrawn | |
| B65 U 44E | Withdrawn | |
| B95 U 43F | Withdrawn | |
| B91 L X | Withdrawn | |
| B91 U 25G | Withdrawn | |
| B55 U 62E | Withdrawn | |
| B55 L R | Withdrawn | |
| B59 U 55D | Withdrawn | |
| B94 U 46E | Withdrawn | |
| B65 L W | Withdrawn | |
| B52 U 31FS | Withdrawn | |
| B91 U 75G | Withdrawn | |
| B66 L Y | Withdrawn | |
| B52 U 13D | Withdrawn | |
| B81 U 76D | Withdrawn | |
| B81 L G | Withdrawn | |
| B77 U 11H | Withdrawn | |
| B77 L H | Withdrawn | |
| B55 U 13D | Withdrawn | |
| B81 U 13E | Withdrawn | |
| B66 U 13E | Withdrawn | |
| B65 L U | Withdrawn | |
| B81 L W | Withdrawn | |
| B95 U 42G | Withdrawn | |
| B52 U 74E | Withdrawn | |
| B91 U 52C | Withdrawn | |
| B69 L W | Withdrawn | |
| B59 U 21J | Withdrawn | |
| B66 L J | Withdrawn | |
| B51 U 45HS | Withdrawn | |
| B81 L V | Withdrawn | |
| B94 U 55F | Withdrawn | |
| B59 U 13E | Withdrawn | |
| B94 U 74H | Withdrawn | |
| B62 U 13D | Withdrawn | |
| B52 U 51F | Withdrawn | |
| B67 U 75G | Withdrawn | |
| B81 U 21D | Withdrawn | |
| B69 U 36F | Withdrawn | |
| B65 U 12F | Withdrawn | |
| B62 U 44F | Withdrawn | |
| B51 U 31F | Withdrawn | |
| B66 U 76G | Withdrawn | |
| B55 U 42F | Withdrawn | |
| B59 L Z | Withdrawn | |
| B51 U 12F | Withdrawn | |
| B55 U 22G | Withdrawn | |
| B52 U 12ES | Withdrawn | |
| B66 L U | Withdrawn | |
| B59 L F | Withdrawn | |
| B66 U 64F | Withdrawn | |
| B94 U 31F | Withdrawn | |
| B95 U 12F | Withdrawn | |
| B65 U 13D | Withdrawn | |
| B91 L E | Withdrawn | |
| B69 L S | Withdrawn | |
| B51 L N | Withdrawn | |
| B66 U 62G | Withdrawn | |
| B59 U 42FS | Withdrawn | |
| B59 U 21C | Withdrawn | |
| B91 U 51F | Withdrawn | |
| B55 U 31F | Withdrawn | |
| B94 U 21D | Withdrawn | |
| B69 L K | Withdrawn | |
| B77 L L | Withdrawn | |
| B94 L R | Withdrawn | |
| B51 L K | Withdrawn | |
| B59 U 12E | Withdrawn | |
| B69 U 62E | Withdrawn | |
| B52 L G | Withdrawn | |
| B66 L K | Withdrawn | |
| B94 U 45H | Withdrawn | |
| B62 U 76D | Withdrawn | |
| B51 U 65G | Withdrawn | |
| B52 U 55F | Withdrawn | |
| B59 U 22G | Withdrawn |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Duo:PCH® | DEN-MAT Holdings, LLC | 29 |
| Vivid ZirDisc Wieland System | Pearson Dental Supplies, Inc. | 27 |
Showing 12 of 25. All products under Teeth, Porcelain
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K880774 | 1988-05-18 |
| K864724 | 1987-02-17 |
| K860608 | 1986-03-26 |
| K823744 | 1982-12-28 |
| K771179 | 1977-07-15 |
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.