Xeno® IV One Component Light Cured Self-Etching Dental Adhesive
Xeno® IV One Component Self-Etching Dental Adhesive Refill Package, 2 (4.5ml) Bottles
6manufacturers in China registered for this device type
4catalogue numbers in this listing
23510(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 | Dentsply LLC, United States |
|---|---|
| FDA product code | KLE |
| Device type | Agent, Tooth Bonding, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3200 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K041343 |
| Record published | 2016-09-21 |
| Record revised | 2022-10-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C; Special storage condition: Keep away from sunlight. Keep dry. |
| Packaging | Box of 6 |
| Sizes | Total volume 4.5 ml |
| Distribution end date | 2019-10-28 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 668001 | 1 Bottle Xeno® IV (4.5mL), 100 Flocked Applicator Tips, 1 Dispensing Well | In distribution | |
| 668004 | 2 Bottles Xeno® IV (4.5mL) | 2 | In distribution |
| 668002 | 100 Unit Doses Xeno® IV, 100 Flocked Applicator Tips, 3 Unit Holders | 100 | In distribution |
| 668005 | Xeno® IV bottle (4.5mL), 50 Flocked Applicator Tips, and 1 Mixing Tray | Withdrawn |
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 |
|---|---|
| K151619 | 2015-10-30 |
| K070538 | 2007-03-14 |
| K051707 | 2005-07-15 |
| K051463 | 2005-07-12 |
| K050386 | 2005-02-23 |
| K041343 | 2004-06-16 |
| K023776 | 2003-01-23 |
| K982394 | 1998-09-21 |
| K982007 | 1998-07-22 |
| K964525 | 1997-01-22 |
| K962348 | 1996-07-18 |
| K960823 | 1996-04-26 |
| K951864 | 1995-05-23 |
| K941572 | 1994-06-10 |
| K931812 | 1993-07-08 |
| K930504 | 1993-05-27 |
| K915830 | 1992-03-02 |
| K891455 | 1989-05-18 |
| K874074 | 1987-12-29 |
| K863522 | 1986-09-19 |
| K852660 | 1985-07-25 |
| K851056 | 1985-04-22 |
| K801093 | 1980-05-20 |
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.