Lexicon
Gutta-Percha 120 04 15 Lexicon
42manufacturers in China registered for this device type
60catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (9), Shanghai (8), Jiangsu (6). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
| Dentsply Dental (Tianjin) Co., Ltd. | Teda | Tianjin | Contract manufacturer | 2 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Anqing Clean Dental Instrument Technology Co., Ltd. | Anqing | Anhui | Manufacturer | 50 |
| Shanghai Dochem Industries Co., Ltd. | Shanghai | Shanghai | Manufacturer | 45 |
Showing 12 of 42. All 42 manufacturers in China registered for Gutta-Percha
Record
| Listed by | Tulsa Dental Products LLC, United States |
|---|---|
| FDA product code | EKM |
| Device type | Gutta-Percha |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3850 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-08-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Liquid Chemical |
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GPXFNC120 | In distribution | |
| GP0415 | In distribution | |
| GP120ISOC120 | In distribution | |
| GP35ISOC120 | In distribution | |
| GP0615 | In distribution | |
| GP60NC120 | In distribution | |
| GPASTNC120 | In distribution | |
| GPMNC120 | In distribution | |
| GPMFNC120 | In distribution | |
| GP50NC120 | In distribution | |
| GP20NC120 | In distribution | |
| GP45NC120 | In distribution | |
| GP0640 | In distribution | |
| GP0425 | In distribution | |
| GP0435 | In distribution | |
| GP0440 | In distribution | |
| GP0490 | In distribution | |
| GPFMNC120 | In distribution | |
| GP40NC120 | In distribution | |
| GPLNC120 | In distribution | |
| GP100NC120 | In distribution | |
| GP04AS | In distribution | |
| GP80NC120 | In distribution | |
| GP70NC120 | In distribution | |
| GP15ISOC120 | In distribution | |
| GP55ISOC120 | In distribution | |
| GP15NC120 | In distribution | |
| GP70ISOC120 | In distribution | |
| GP110ISOC120 | In distribution | |
| GP30ISOC120 | In distribution | |
| GP90NC120 | In distribution | |
| GP20ISOC120 | In distribution | |
| GP60ISOC120 | In distribution | |
| GP0420 | In distribution | |
| GP40ISOC120 | In distribution | |
| GP50ISOC120 | In distribution | |
| GP0625 | In distribution | |
| GP100ISOC120 | In distribution | |
| GP25ISOC120 | In distribution | |
| GP55NC120 | In distribution | |
| GP1540NC120 | In distribution | |
| GP1540ISOC120 | In distribution | |
| GPXLNC120 | In distribution | |
| GP0620 | In distribution | |
| GP06AS | In distribution | |
| GP0630 | In distribution | |
| GP45ISOC120 | In distribution | |
| GPFNC120 | In distribution | |
| GP0445 | In distribution | |
| GP0635 | In distribution | |
| GP110NC120 | In distribution | |
| GP0430 | In distribution | |
| GP30NC120 | In distribution | |
| GP90ISOC120 | In distribution | |
| GPFFNC120 | In distribution | |
| GP25NC120 | In distribution | |
| GP120NC120 | In distribution | |
| GP35NC120 | In distribution | |
| GP0460 | In distribution | |
| GP80ISOC120 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Gutta Percha Points | Diadent Group Intl., Inc. | 1,404 |
| MM Marked Gutta Percha Points | Diadent Group Intl., Inc. | 683 |
| Henry Schein | Henry Schein, Inc. | 386 |
| Zarc | Shanghai Xing YU Medical Equipment Co., Ltd. | 166 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 130 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 126 |
| Avalon Biomed | Shanghai Xing YU Medical Equipment Co., Ltd. | 106 |
| Advance Dental Products | THE Atlanta Dental Supply Company | 97 |
| Safco gutta percha points | Safco Dental Supply | 90 |
| Sure-endo | Sure Dent Corporation | 89 |
| 3D Endo | 3D Dental Designs AND Development, LLC | 82 |
| Endodontic Obturators | Tulsa Dental Products LLC | 78 |
Showing 12 of 599. All products under Gutta-Percha
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K970134 | 1997-03-21 |
| K910224 | 1991-03-29 |
| K900986 | 1990-11-13 |
| K881139 | 1988-04-07 |
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.