Tenure®
TENURE UBOND SOL B 6mL RFL KIT
6manufacturers in China registered for this device type
12catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jilin (2), Liaoning (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Liaoning Upcera Co., Ltd. | Benxi | Liaoning | Contract manufacturer | 10 |
| Shenzhen Upcera Digital Dental Technology Co., Ltd. | Shenzhen | Guangdong | Exporter | 10 |
| Rizhao Huge Biomaterials Company, Ltd. | Rizhao | Shandong | Manufacturer | 7 |
| CAO (China) Medical Equipment Company, Limited | Langfang | Hebei | Contract manufacturer | 6 |
| Sincera Technology (Changchun) Co., Ltd. | Changchun | Jilin | Manufacturer | 2 |
| Sino-Dentex Co., Ltd. | Changchun | Jilin | Manufacturer | 2 |
Record
| Listed by | DEN-MAT Holdings, LLC, United States |
|---|---|
| FDA product code | KLE |
| Device type | Agent, Tooth Bonding, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3200 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K801216 |
| Record published | 2016-09-24 |
| Record revised | 2024-02-16 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Recommended temperature when used is 70° – 75° F (21° – 24° C).; Special storage condition: ” Do not expose to direct sunlight..”; Special storage condition: Do not expose to temperatures exceeding 80° F (27° C).; Special storage condition: Do not freeze or refrigerate; Storage environment temperature 36 to 77 °F; Handling environment temperature 36 to 77 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 030411900 | In distribution | |
| 039811401 | In distribution | |
| 039814000 | In distribution | |
| 030451010 | In distribution | |
| 030412902 | In distribution | |
| 031145700 | In distribution | |
| 031145110B | In distribution | |
| TEN4000 | In distribution | |
| 031145300 | In distribution | |
| 032245101B | In distribution | |
| 031145100 | In distribution | |
| 030412901 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epic® | Parkell, Inc. | 22 |
| All-Bond Universal | Bisco, Inc. | 18 |
| Henry Schein | Henry Schein, Inc. | 16 |
| Peak Universal Bond | Ultradent Products Inc. | 16 |
| Brush&Bond® | Parkell, Inc. | 16 |
| All-Bond 2 | Bisco, Inc. | 15 |
| The Orthodontic Store | Young Innovations Inc. | 15 |
| All-Bond 3 | Bisco, Inc. | 13 |
| Scotchbond™ Universal | 3M Deutschland GmbH | 13 |
| Select HV Etch w/BAC | Bisco, Inc. | 12 |
| Prelude | Danville Materials, LLC | 12 |
| Jade | Dharma Research, Inc. | 12 |
Showing 12 of 609. All products under Agent, Tooth Bonding, Resin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K140537 | 2014-08-20 |
| K860971 | 1986-03-25 |
| K801216 | 1980-05-28 |
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.