Amalgambond®
Accessory Kit AmalgamBond®: (1-Brush Handle, 100- Disposable Brush Tips, 1-Spatula, 3-Measuring Spoons, 2 mixing wells)
6manufacturers in China registered for this device type
9catalogue numbers in this listing
16510(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 | Parkell, Inc., 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, Manufacturer |
| Record published | 2018-11-23 |
| Record revised | 2024-02-16 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: May be refrigerated but not frozen.; Storage environment temperature 1 to 30 °C |
| Distribution end date | 2019-01-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S376 | In distribution | |
| S370 | In distribution | |
| S371 | In distribution | |
| S372 | In distribution | |
| S374 | In distribution | |
| S375 | In distribution | |
| S372 | Withdrawn | |
| S370 | Withdrawn | |
| S376 | Withdrawn |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 |
|---|---|
| K172176 | 2017-11-21 |
| K151518 | 2015-09-18 |
| K142848 | 2015-02-24 |
| K032179 | 2003-09-09 |
| K020239 | 2002-03-20 |
| K994302 | 2000-02-07 |
| K972421 | 1997-08-29 |
| K964867 | 1997-04-11 |
| K960879 | 1996-03-22 |
| K952123 | 1995-06-20 |
| K952124 | 1995-06-20 |
| K950905 | 1995-04-10 |
| K942017 | 1994-07-06 |
| K895750 | 1989-12-21 |
| K892003 | 1989-06-07 |
| K884918 | 1989-02-13 |
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.