A. Titan Instruments
Easy X-Trac System, includes: XT101, XT140L, XT140R, XT120, XT110, XT128, XT133, XT171
20manufacturers in China registered for this device type
64catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (4), Anhui (4), Hebei (3). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shandong Zhushi Pharmaceutical Group Co., Ltd. | Heze | Shandong | Contract manufacturer | 65 |
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Anqing Clean Dental Instrument Technology Co., Ltd. | Anqing | Anhui | Manufacturer | 50 |
| Anhui Medpurest Medical Technology Co., Ltd. | Anqing | Anhui | Manufacturer | 46 |
| Cangzhou Lankang Medical Instruments Developing Co., Ltd. | Cangzhou | Hebei | Manufacturer | 40 |
| Anqing Kangmingna Packaging Co., Ltd. | Anqing | Anhui | Contract manufacturer | 39 |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | Yang Jiao Lang Zin’An Town | Zhejiang | Manufacturer | 39 |
Showing 12 of 20. All 20 manufacturers in China registered for Forceps, Tooth Extractor, Surgical
Record
| Listed by | A. Titan Instruments, Inc., United States |
|---|---|
| FDA product code | EMG |
| Device type | Forceps, Tooth Extractor, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K060691 |
| Record published | 2023-01-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Dry Heat Sterilization |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 151+ | In distribution | |
| XT 135 | In distribution | |
| XT 136 | In distribution | |
| 17 H | In distribution | |
| K-8100 | In distribution | |
| 1274 E | In distribution | |
| 1274 | In distribution | |
| 150 AS | In distribution | |
| XT 111 | In distribution | |
| XT 128 | In distribution | |
| 1251 N | In distribution | |
| XT 113 | In distribution | |
| 1179 | In distribution | |
| 0700 | In distribution | |
| 150P+ | In distribution | |
| 151 | In distribution | |
| 151P+ | In distribution | |
| 1245 E | In distribution | |
| 7990 | In distribution | |
| 1P+ | In distribution | |
| 1251 ND | In distribution | |
| XT 115 | In distribution | |
| 133 AS | In distribution | |
| XT 120 | In distribution | |
| K-4300 | In distribution | |
| 1800 | In distribution | |
| 150 SK | In distribution | |
| 150 AB | In distribution | |
| XT 140 L | In distribution | |
| 151 AB | In distribution | |
| K-8000 II | In distribution | |
| 1174 XN | In distribution | |
| XT 150 | In distribution | |
| 1010 | In distribution | |
| K-4200 | In distribution | |
| 150+ | In distribution | |
| 1 | In distribution | |
| 1274 N | In distribution | |
| XT 140 R | In distribution | |
| 1167 D | In distribution | |
| 1167 | In distribution | |
| 18 H | In distribution | |
| 150 S | In distribution | |
| XT 101 | In distribution | |
| 1700 | In distribution | |
| 1245 ND | In distribution | |
| 1274 ND | In distribution | |
| 151 SK | In distribution | |
| 1107 D | In distribution | |
| 1107 | In distribution | |
| XT-110 (Set) | In distribution | |
| 1102 | In distribution | |
| XT 130 | In distribution | |
| 151 S | In distribution | |
| XT 133 | In distribution | |
| XT 171 | In distribution | |
| 1107 N | In distribution | |
| XT 170 | In distribution | |
| 1251 E | In distribution | |
| XT CD | In distribution | |
| XT 100 | In distribution | |
| 150 | In distribution | |
| 1+ | In distribution | |
| 151 AS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| devemed | Devemed Gmbh | 266 |
| Reicodent | Devemed Gmbh | 229 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 209 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 193 |
| Power Dental USA | Power Dental U.S.A. Inc. | 175 |
| Forceps | KLS-Martin L.P. | 174 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 166 |
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 149 |
| Paul Banditt | Terlain Enterprises, Inc. | 147 |
| Kohdent | Kohler Medizintechnik GmbH | 141 |
| Sklar® | Sklar Corporation | 133 |
| Extraction Forceps | Melpex Beauty Instruments | 125 |
Showing 12 of 242. All products under Forceps, Tooth Extractor, Surgical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K060691 | 2006-06-12 |
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.