Triad®
Regular Pink Unfibered (Sheets)
14manufacturers in China registered for this device type
39catalogue numbers in this listing
18510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (6), Zhejiang (2), Hebei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Aidite (Qinhuangdao) Technology Co., Ltd. | Qinhuangdao | Hebei | Repacker / relabeller | 17 |
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Shen FU Arts LAB | Shen Zhen | Guangdong | Manufacturer | 15 |
| Liaoning Upcera Co., Ltd. | Benxi | Liaoning | Contract manufacturer | 10 |
| Shenzhen Upcera Digital Dental Technology Co., Ltd. | Shenzhen | Guangdong | Exporter | 10 |
| Riton 3D Technology Co., Ltd. | Guangzhou | Guangdong | Repacker / relabeller | 9 |
| Yamahachi Dental Material (Changshu) Co., Ltd. | Changshu | Jiangsu | Manufacturer | 9 |
| Guangzhou Heygears Imc.inc | Guangzhou | Guangdong | Specification developer | 8 |
| Hangzhou SHINING3D Dental Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 7 |
| Ningbo Sezen Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 7 |
| Hunan Vsmile Biotechnology Co., Ltd. | Changsha | Hunan | Contract manufacturer | 6 |
| Shenzhen Piocreat 3D Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
Showing 12 of 14. All 14 manufacturers in China registered for Resin, Denture, Relining, Repairing, Rebasing
Record
| Listed by | Dentsply LLC, United States |
|---|---|
| FDA product code | EBI |
| Device type | Resin, Denture, Relining, Repairing, Rebasing |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3760 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-21 |
| Record revised | 2022-05-06 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Weight 22 to 394 g; weight 0.5 to 2.51 kg; total volume 20 ml |
| Distribution end date | 2022-05-05 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Hi-Flow Reline Material | Weight 101 g | 6 | Withdrawn |
| Original Flow Reline Material | Weight 0.5 kg | 30 | Withdrawn |
| Material Sample Kit | Contains: 1 DuaLine Refill Package, 2 Sheets Hi-Flow Reline Material, 2 Sheets Denture Base, 2 Ropes Denture Base, 3 Ropes Provisional Material, 1 Tube Gel, 2 Sheets TranSheet Material | Withdrawn | |
| Original Flow Reline Material | Weight 101 g | 6 | Withdrawn |
| TranSheet® Material | Weight 0.5 kg | 50 | Withdrawn |
| Denture Base Material | Weight 39.5 g | 6 | Withdrawn |
| Gel Clear Pink | Each tube is 22 grams | 4 | Withdrawn |
| Denture Base Material | Weight 0.5 kg | 30 | Withdrawn |
| DuaLine® Refill Package | Weight 56 g | 2 | Withdrawn |
| TranSheet® Material | Weight 65 g | 4 | Withdrawn |
| Denture Base Material | Weight 2.51 kg | 150 | Withdrawn |
| Original Flow Reline Material | Weight 101 g | 6 | Withdrawn |
| Hi-Flow Reline Material | Weight 101 g | 6 | Withdrawn |
| Gel Clear Colorless | Each tube is 22 grams | 4 | Withdrawn |
| Denture Base Material | Weight 39.5 g | 6 | Withdrawn |
| Denture Base Material | Weight 0.5 kg | 30 | Withdrawn |
| TranSheet® Material | Weight 65 g | 4 | Withdrawn |
| VLC Bonding Agent | Total Volume 20 ml | Withdrawn | |
| Denture Base Material | Weight 0.5 kg | 30 | Withdrawn |
| Gel Clear Blue | Each tube is 22 grams | 4 | Withdrawn |
| TranSheet® Material | Weight 0.5 kg | 50 | Withdrawn |
| Denture Base Material | Weight 2.51 kg | 150 | Withdrawn |
| Accessory Package | Total Volume 20 ml | Withdrawn | |
| Original Flow Reline Material | Weight 39.5 g | 6 | Withdrawn |
| Denture Base Material | Weight 39.5 g | 6 | Withdrawn |
| Gel Assortment Package | Weight 22 g | Withdrawn | |
| Hi-Flow Reline Material | Weight 0.5 kg | 30 | Withdrawn |
| Denture Base Material | Weight 101 g | 6 | Withdrawn |
| Original Flow Reline Material | Weight 0.5 kg | 30 | Withdrawn |
| Denture Base Material | Weight 101 g | 6 | Withdrawn |
| Original Flow Reline Material | Weight 39.5 g | 6 | Withdrawn |
| Denture Base Material | Weight 101 g | 6 | Withdrawn |
| DuaLine® Introductory Package | Contains two (2) 56 gram DuaLine cartridges One (1) 20 millileter Bonding Agent | Withdrawn | |
| TranSheet® Material | Weight 394 g | 24 | Withdrawn |
| Gel Clear Red | Weight 22 g | 4 | Withdrawn |
| Denture Base Material | Weight 101 g | 6 | Withdrawn |
| Denture Base Material | Weight 2.51 kg | 150 | Withdrawn |
| TranSheet® Material | Weight 394 g | 24 | Withdrawn |
| Hi Flow Reline Material | Weight 0.5 kg | 30 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vertex-Dental BV | Vertex-Dental B.V. | 760 |
| HI-I® | Fricke International, Inc. | 490 |
| Vitacrilic® | Fricke International, Inc. | 249 |
| Nature-Cryl® | GC America Inc. | 205 |
| Nobilium | Cmp Industries, LLC | 167 |
| Hygenic | Coltene/Whaledent Gmbh & Co. KG | 152 |
| AvaDent | Global Dental Science | 150 |
| Dentorium | Wright Medical Technology, Inc. | 137 |
| Duracetal | The Myerson Company Limited | 136 |
| RE-Fine Bright | Yamahachi Dental MFG. Co. | 134 |
| Axcent Acrylics | Garreco, LLC | 132 |
| Unbreakable by TCS | Thermoplastic Comfort SYS | 96 |
Showing 12 of 3,288. All products under Resin, Denture, Relining, Repairing, Rebasing
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K072713 | 2007-10-12 |
| K061580 | 2006-07-28 |
| K032892 | 2003-09-26 |
| K011560 | 2001-07-12 |
| K992956 | 1999-10-06 |
| K972573 | 1997-09-16 |
| K964040 | 1996-12-06 |
| K952351 | 1995-07-07 |
| K926406 | 1993-03-31 |
| K905702 | 1991-04-29 |
| K895742 | 1989-12-18 |
| K882482 | 1988-08-12 |
| K863324 | 1986-09-05 |
| K834409 | 1984-02-27 |
| K831647 | 1983-06-30 |
| K800400 | 1980-03-12 |
| K792042 | 1979-11-30 |
| K780786 | 1978-06-14 |
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.