Esthet-X®flow Liquid Micro Hybrid
Esthet-X®flow Liquid Micro Hybrid, Bleach, 20 Compula® Tips Refill Package
3manufacturers in China registered for this device type
24catalogue 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 | 2016-09-23 |
| Record revised | 2023-08-31 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| 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 0.25 to 1.3 g |
| Distribution end date | 2022-07-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 648116 | Esthet-X®flow Liquid Micro Hybrid A3.5, 20 Compula® Tips | 20 | In distribution |
| 648029 | Weight 1.3 g | 2 | In distribution |
| 648111 | Weight 0.25 g | 20 | In distribution |
| 648021 | Weight 1.3 g | 2 | In distribution |
| 648117 | Esthet-X®flow Liquid Micro Hybrid, Bleach, 20 Compula® Tips | 20 | In distribution |
| 648003 | 60 Syringe Tips | 60 | In distribution |
| 648020 | Weight 1.3 g | 2 | In distribution |
| 648113 | Weight 0.25 g | 20 | In distribution |
| 648115 | Esthet-X®flow Liquid Micro Hybrid U, 20 Compula® Tips | 20 | In distribution |
| 648114 | Esthet-X®flow Liquid Micro Hybrid B1, 20 Compula® Tips | 20 | In distribution |
| 648112 | Weight 0.25 g | 20 | In distribution |
| 648118 | Esthet-X®flow Liquid Micro Hybrid C4, 20 Compula® Tips | 20 | In distribution |
| 648022 | Esthet-X®flow Liquid Micro Hybrid, A3, 1 (1.3g) Syringe Refill and 30 Syringe Tips | 2 | In distribution |
| 648024 | Esthet-X®flow Liquid Micro Hybrid, B1, 1 (1.3g) Syringe Refill and 30 Syringe Tips | 2 | In distribution |
| 648119 | Esthet-X®flow Liquid Micro Hybrid, A2.0, 20 Compula® Tips | 20 | In distribution |
| 648110 | Esthet-X®flow Liquid Micro Hybrid A1, 20 Compula® Tips | 20 | In distribution |
| 648026 | Esthet-X®flow Liquid Micro Hybrid, A3.5, 1 (1.3g) Syringe Refill and 30 Syringe Tips | 2 | In distribution |
| 648027 | Esthet-X®flow Liquid Micro Hybrid, BW, 1 (1.3g) Syringe Refill and 30 Syringe Tips | 2 | In distribution |
| 648025 | Esthet-X®flow Liquid Micro Hybrid, LYG, 1 (1.3g) Syringe Refill and 30 Syringe Tips | 2 | In distribution |
| 648023 | Esthet-X®flow Liquid Micro Hybrid, A4, 1 (1.3g) Syringe Refill and 30 Syringe Tips | 2 | In distribution |
| 648028 | Weight 1.3 g | 2 | In distribution |
| 648002 | Weight 0.65 g | Withdrawn | |
| 648001 | Weight 1.3 g | Withdrawn | |
| 648101 | 24 Tips, 1 Tips Gun, 1 Syringe Tooth Cond Gel, 25 Applicator Needles, 20 Unit Doses Adhesive, 1 Unit Dose Holder, 20 Applicator Tips, Enhance Finishing Sample, Polishing Sample, Tips Sample | 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 |
| Photac™ Fil Quick Aplicap™ | 3M Deutschland GmbH | 24 |
| Ketac™ Fil Plus Aplicap™ | 3M Deutschland GmbH | 23 |
| Ultra-Bond® | DEN-MAT Holdings, LLC | 23 |
| TPH®3 flow Liquid Micro Hybrid | Dentsply LLC | 22 |
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.