Calibra® Esthetic Resin Cement
Calibra® Esthetic Resin Cement, Catalyst, Regular Viscosity, 1 (2g) syringe Refill Package
3manufacturers in China registered for this device type
20catalogue 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 |
| 510(k) | K040906 |
| Record published | 2016-09-21 |
| Record revised | 2024-05-02 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep away from sunlight. Keep dry. |
| Sizes | Weight 1.8 to 4.5 g |
| Distribution end date | 2024-05-02 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 607084 | 1 Dual Cure Automix Syringe (4.5g) and 10 Mixing Tips | In distribution | |
| 607083 | Weight 4.5 g | In distribution | |
| 607064 | 1 Syringe Calibra® Base Shade (2g), Translucent | In distribution | |
| 607061 | 1 Syringe Calibra® Base Shade (2g), Light | In distribution | |
| 607063 | 1 Syringe Calibra® Base Shade (2g), Dark | In distribution | |
| 607062 | 1 Syringe Calibra® Base Shade (2g), Medium | In distribution | |
| 607085 | 1 Dual Cure Automix Syringe (4.5g) and 10 Mixing Tips | In distribution | |
| 607069 | 1 Syringe Calibra® Catalyst (2g), High Viscosity | In distribution | |
| 607065 | Weight 2 g | In distribution | |
| 607068 | 1 Syringe Calibra® Catalyst (2g), Regular Viscosity | In distribution | |
| 607082 | Weight 4.5 g | In distribution | |
| 607081 | Weight 4.5 g | In distribution | |
| 607057 | Weight 2 g | In distribution | |
| 607073 | Weight 1.8 g | 2 | Withdrawn |
| 607058 | Weight 1.8 g | Withdrawn | |
| 607075 | Weight 1.8 g | 2 | Withdrawn |
| 607072 | 2 Syringes Calibra® Try-In Paste (1.8g each) | 2 | Withdrawn |
| 607071 | 2 Syringes Calibra® Try-In Paste (1.8g each) | 2 | Withdrawn |
| 607074 | Weight 1.8 g | 2 | Withdrawn |
| 607056 | 1 Dual Cure Automix Syringe, 5 Mixing Tips | 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 |
|---|---|
| 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.