Calibra® Universal+ Versatile Resin Cement
Calibra® Universal+ Syringe Refill - Translucent Shade
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 | 2024-05-17 |
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: Protect from moisture.; Storage environment temperature 2 to 35 °C; Special storage condition: Do not freeze.; Special storage condition: Keep out of direct sunlight.; Special storage condition: Use the product at room temperature.; Special storage condition: Store in a well-ventilated place. |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 607402NA | 2 Syringes (4.5g each); 20 Mixing Tips | 2 | In distribution |
| 607400NA | 5 Syringes (4.5g each), 1 in each shade (Light, Medium, Translucent, Opaque, Bleach); 50 Mixing Tips | 5 | In distribution |
| 607405NA | 2 Syringes (4.5g each); 20 Mixing Tips | 2 | In distribution |
| 607406NA | 2 Syringes (4.5g each); 20 Mixing Tips | 2 | In distribution |
| 607407NA | 2 Syringes (4.5g each); 20 Mixing Tips | 2 | In distribution |
| 607410NA | 2 Syringes (4.5g each); 20 Mixing Tips | In distribution | |
| 607403NA | 2 Syringes (4.5g each); 20 Mixing Tips | 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.