Dentall, Inc.
Manufacturer and brand owner in District, Beijing, China. 13 device types, 7 products catalogued, 3 clearances.
Dentall, Inc. is a contract manufacturer holding a current FDA establishment registration. The registration covers Dentures, Full, Crown, Preformed and 11 other device types. 7 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2006.
13device types registered with the FDA
7products catalogued under its own name
3510(k) clearances
Registration
| Registered name | DENTALL, INC. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3005735859 |
| FEI number | 3005735859 |
| DUNS | 690440554 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Location
| City | District |
|---|---|
| Province | Beijing |
| Address | THE STANDARD WORKSHOP,TIAN-ZHU |
| Postal code | 101312 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Activator, Ultraviolet, For Polymerization | Class 2 | B&Lite S | 2017 | 7 |
| Camera, Surgical And Accessories | Class 1 | Camstar, LED IC 100, Opti plus HD, EzCam, ProXam iCam, Somia | 2011 | 22 |
| Crown, Preformed | Class 1 | Dentalle Zirconia Cown | 2006 | 23 |
| Dentures, Full | Class N | Dentalle Full Denture | 2020 | 50 |
| Dentures, Partial | Class N | Dentalle Partial Denture | 2012 | 55 |
| Material, Impression Tray, Resin | Class 1 | Resin Model | 2023 | 41 |
| Restoration, Base Metal | Class N | Dentalle PFM Crown | 2012 | 43 |
| Restoration, Noble Metal | Class N | Dentalle Noble Crown | 2012 | 42 |
| Restoration, Porcelain | Class N | Dentalle Porcelain Crown | 2012 | 50 |
| Restoration, Porcelain-Fused-To-Metal | Class N | Dentalle PFM | 2012 | 50 |
| Restoration, Resin | Class N | Dentalle Resin Crown | 2012 | 17 |
| Restoration, Resin, Crown And Bridge | Class N | Dentalle Temp Crown | 2012 | 35 |
| Tray, Impression, Preformed | Class 1 | Impression | 2006 | 73 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| B&Lite S | EBZ | 6 |
| EzCam | KQM | 4 |
| LED IC100 | KQM | 2 |
| Camstar | KQM | 2 |
| Opti plus HD | KQM | 2 |
| IOC-Holder | KQM | 1 |
| IOC-USB Cable | KQM | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K170529 | 2017-08-08 | EBZ | Traditional | This company |
| K140432 | 2015-08-03 | EBZ | Traditional | This company |
| K061658 | 2006-09-18 | EBZ | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Dental laboratory services |
|---|
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.
The manufacturer named here can complete this record.