Calibra® Universal Self-Adhesive Resin Cement
Calibra® Universal Cement Dual Cure Automix Syringe Refill Package, Translucent, 2 syringe (4.5g)
3manufacturers in China registered for this device type
7catalogue numbers in this listing
20510(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 | Dentsply LLC, 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, Exporter |
| Record published | 2022-09-20 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Allow material to reach room temperature prior to use.; Special storage condition: Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.; Special storage condition: Keep out of direct sunlight and store in a well ventilated place at temperatures between 2°-24° Celsius.; Special storage condition: Protect from moisture.; Special storage condition: Do not freeze.; Storage environment temperature 2 to 24 °C |
| Sizes | Weight 4.5 g |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 607410 | 1 Syringe (2g) and 10 Mixing Tips | In distribution | |
| 607403 | Weight 4.5 g | 2 | In distribution |
| 607400 | 5 Dual Cure AutoMix Syringes (4.5g) – 1 each shade: Light, Medium, Translucent, Opaque, Bleach; 50 Mixing Tips | In distribution | |
| 607402 | Weight 4.5 g | 2 | In distribution |
| 607407 | 2 Syringes (4.5g) each and 20 Mixing Tips | 2 | In distribution |
| 607405 | 2 Dual Cure AutoMix Syringes (4.5g) – Translucent – and 20 Mixing Tips | 2 | In distribution |
| 607406 | Weight 4.5 g | 2 | In distribution |
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 |
|---|---|
| K101493 | 2010-08-19 |
| K041272 | 2004-10-18 |
| K040906 | 2004-06-16 |
| K040895 | 2004-05-21 |
| K003921 | 2001-01-24 |
| K981965 | 1998-07-10 |
| K974140 | 1998-01-05 |
| K940914 | 1994-08-29 |
| K940459 | 1994-04-29 |
| K931229 | 1993-07-08 |
| K923473 | 1993-04-12 |
| K923328 | 1992-09-09 |
| K913836 | 1991-10-17 |
| K901524 | 1990-09-19 |
| K896340 | 1990-05-15 |
| K895487 | 1990-04-02 |
| K874945 | 1988-02-19 |
| K864720 | 1987-04-07 |
| K864725 | 1987-01-21 |
| K812858 | 1981-12-31 |
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.