Ketac™
3M™ ESPE™ Ketac™ Nano Light-Curing Glass Ionomer Quick Mix Capsule Shade A1 Sample Kit, 3305A1-S
3manufacturers in China registered for this device type
17catalogue numbers in this listing
12510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shandong (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Rizhao Huge Biomaterials Company, Ltd. | Rizhao | Shandong | Manufacturer | 7 |
| Shenzhen Upcera Dental Technology Co., Ltd. | Shenzhen | Guangdong | Private-label distributor | 6 |
Record
| Listed by | 3M Company, United States |
|---|---|
| FDA product code | EMA |
| Device type | Cement, Dental |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3275 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-24 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 10 |
| Distribution end date | 2017-02-13 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 3305A3.5 | 20 | In distribution | |
| 3304TK | In distribution | ||
| 3304B2 | In distribution | ||
| 3305TK | In distribution | ||
| 3305A3-S | 20 | In distribution | |
| 3304I | In distribution | ||
| 3305A4 | 20 | In distribution | |
| 3304A3 | In distribution | ||
| 3304A2 | In distribution | ||
| 3305A2 | 20 | In distribution | |
| 3305A3 | 20 | In distribution | |
| 3304P | In distribution | ||
| 3304A1 | In distribution | ||
| 3304A3.5 | In distribution | ||
| 3305B2 | 20 | In distribution | |
| 3305A1 | 20 | In distribution | |
| 3305A1-S | 20 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GC Fuji II LC® | GC America Inc. | 78 |
| Equia® | GC America Inc. | 73 |
| Riva SC | SDI Ltd. | 72 |
| Denture Base | American Tooth Industries | 61 |
| Riva LC | SDI Ltd. | 59 |
| GC Fuji IX GP® | GC America Inc. | 58 |
| GlasIonomer FX-LC | Shofu Dental Corp. | 45 |
| Henry Schein | Henry Schein, Inc. | 35 |
| Esthet-X®flow Liquid Micro Hybrid | Dentsply LLC | 24 |
| Photac™ Fil Quick Aplicap™ | 3M Deutschland GmbH | 24 |
| Ketac™ Fil Plus Aplicap™ | 3M Deutschland GmbH | 23 |
| Ultra-Bond® | DEN-MAT Holdings, LLC | 23 |
Showing 12 of 780. All products under Cement, Dental
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170330 | 2017-02-06 |
| K052235 | 2005-09-27 |
| K022476 | 2002-08-02 |
| K011200 | 2001-06-14 |
| K002452 | 2000-09-28 |
| K973961 | 1997-12-17 |
| K962065 | 1996-07-18 |
| K933139 | 1994-01-05 |
| K925032 | 1992-12-23 |
| K911842 | 1991-06-17 |
| K902041 | 1990-06-27 |
| K864270 | 1986-12-16 |
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.