Eclipse®
Contains: 18 12-pack boxes of Eclipse resins, Bonding Agent Kit, and miscellaneous accessories (non-medical devices)
6manufacturers in China registered for this device type
2catalogue 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 |
| Record published | 2016-09-21 |
| Record revised | 2022-05-06 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Weight 180 g |
| Distribution end date | 2022-05-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Starter Kit #1 | Withdrawn | |
| Eclipse Bonding Agent | Weight 180 g | Withdrawn |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.