MulTipeg™
151 catalogue numbers from MulTipeg™ 40, listed by Integration Diagnostics Sweden AB, Sweden, under Handpiece, Direct Drive, Ac-Powered. 10 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (2), Guangxi (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jung Chen Technology Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 2 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Foshan Coxo Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 19 |
| Denjoy Dental Co., Ltd. | Changsha | Hunan | Contract manufacturer | 17 |
| Foshan Cicada Dental Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 15 |
| Changzhou Sifary Medical Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 14 |
| Shenzhen Superline Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 12 |
| Shenzhen Perfect Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 10 |
| Changzhou Bomedent Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 6 |
Record
| Listed by | Integration Diagnostics Sweden AB, Sweden |
|---|---|
| FDA product code | EKX |
| Device type | Handpiece, Direct Drive, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4200 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K143445 |
| Record published | 2022-03-01 |
| Record revised | 2024-10-31 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MulTipeg™ 40 | In distribution | |
| MulTipeg™ 123 | In distribution | |
| MulTipeg™ 38 | In distribution | |
| MulTipeg™ 16 | In distribution | |
| MulTipeg™ 43 | In distribution | |
| MulTipeg™ 30 | In distribution | |
| MulTipeg™ 71 | In distribution | |
| MulTipeg™ 12 | In distribution | |
| MulTipeg™ 29 | In distribution | |
| MulTipeg™ 114 | In distribution | |
| MulTipeg™ 3 | In distribution | |
| MulTipeg™ 11 | In distribution | |
| MulTipeg™ 77 | In distribution | |
| MulTipeg™ 110 | In distribution | |
| MulTipeg™ 125 | In distribution | |
| MulTipeg™ 42 | In distribution | |
| MulTipeg™ 47 | In distribution | |
| MulTipeg™ 124 | In distribution | |
| MulTipeg™ 148 | In distribution | |
| MulTipeg™ 39 | In distribution | |
| MulTipeg™ 116 | In distribution | |
| MulTipeg™ 145 | In distribution | |
| MulTipeg™ 9 | In distribution | |
| MulTipeg™ 88 | In distribution | |
| MulTipeg™ 99 | In distribution | |
| MulTipeg™ 86 | In distribution | |
| MulTipeg™ 52 | In distribution | |
| MulTipeg™ 111 | In distribution | |
| MulTipeg™ 82 | In distribution | |
| MulTipeg™ 129 | In distribution | |
| MulTipeg™ 56 | In distribution | |
| MulTipeg™ 103 | In distribution | |
| MulTipeg™ 28 | In distribution | |
| MulTipeg™ 112 | In distribution | |
| MulTipeg™ 92 | In distribution | |
| MulTipeg™ 44 | In distribution | |
| MulTipeg™ 45 | In distribution | |
| MulTipeg™ 66 | In distribution | |
| MulTipeg™ 2 | In distribution | |
| MulTipeg™ 41 | In distribution | |
| MulTipeg™ 128 | In distribution | |
| MulTipeg™ 140 | In distribution | |
| MulTipeg™ 68 | In distribution | |
| MulTipeg™ 94 | In distribution | |
| MulTipeg™ 80 | In distribution | |
| MulTipeg™ 36 | In distribution | |
| MulTipeg™ 109 | In distribution | |
| MulTipeg™ 14 | In distribution | |
| MDI MulTipeg™ 151 | In distribution | |
| MulTipeg™ 34 | In distribution | |
| MulTipeg™ 48 | In distribution | |
| MulTipeg™ 118 | In distribution | |
| MulTipeg™ 107 | In distribution | |
| MulTipeg™ 37 | In distribution | |
| MulTipeg™ 119 | In distribution | |
| MulTipeg™ 54 | In distribution | |
| MulTipeg™ 142 | In distribution | |
| MulTipeg™ 4 | In distribution | |
| MulTipeg™ 97 | In distribution | |
| MulTipeg™ 72 | In distribution | |
| MulTipeg™ 31 | In distribution | |
| MulTipeg™ 108 | In distribution | |
| MulTipeg™ 89 | In distribution | |
| MulTipeg™ 73 | In distribution | |
| MulTipeg™ 6 | In distribution | |
| MulTipeg™ 127 | In distribution | |
| MulTipeg™ 35 | In distribution | |
| MulTipeg™ 79 | In distribution | |
| MulTipeg™ 93 | In distribution | |
| MulTipeg™ 10 | In distribution | |
| MulTipeg™ 51 | In distribution | |
| MulTipeg™ 91 | In distribution | |
| MulTipeg™ 21 | In distribution | |
| MulTipeg™ 101 | In distribution | |
| MulTipeg™ 113 | In distribution | |
| MulTipeg™ 90 | In distribution | |
| MulTipeg™ 85 | In distribution | |
| MulTipeg™ 132 | In distribution | |
| MulTipeg™ 83 | In distribution | |
| MulTipeg™ 87 | In distribution | |
| MulTipeg™ 62 | In distribution | |
| MulTipeg™ 7 | In distribution | |
| MulTipeg™ 67 | In distribution | |
| MulTipeg™ 98 | In distribution | |
| MulTipeg™ 50 | In distribution | |
| MulTipeg™ 24 | In distribution | |
| MulTipeg™ 27 | In distribution | |
| MulTipeg™ 115 | In distribution | |
| MulTipeg™ 22 | In distribution | |
| MulTipeg™ 105 | In distribution | |
| MulTipeg™ 58 | In distribution | |
| MulTipeg™ 95 | In distribution | |
| MulTipeg™ 137 | In distribution | |
| MulTipeg™ 149 | In distribution | |
| MulTipeg™ 150 | In distribution | |
| MulTipeg™ 81 | In distribution | |
| MulTipeg™ 5 | In distribution | |
| MulTipeg™ 78 | In distribution | |
| MulTipeg™ 70 | In distribution | |
| MulTipeg™ 19 | In distribution | |
| MulTipeg™ 8 | In distribution | |
| MulTipeg™ 59 | In distribution | |
| MulTipeg™ 136 | In distribution | |
| MulTipeg™ 143 | In distribution | |
| MulTipeg™ 117 | In distribution | |
| MulTipeg™ 18 | In distribution | |
| MulTipeg™ 76 | In distribution | |
| MulTipeg™ 20 | In distribution | |
| MulTipeg™ 25 | In distribution | |
| MulTipeg™ 102 | In distribution | |
| MulTipeg™ 33 | In distribution | |
| MulTipeg™ 64 | In distribution | |
| MulTipeg™ 49 | In distribution | |
| MulTipeg™ 126 | In distribution | |
| MulTipeg™ 32 | In distribution | |
| MulTipeg™ 84 | In distribution | |
| MulTipeg™ 65 | In distribution | |
| MulTipeg™ 146 | In distribution | |
| MulTipeg™ 106 | In distribution | |
| MulTipeg™ 75 | In distribution | |
| MulTipeg™ 1 | In distribution | |
| MulTipeg™ 131 | In distribution | |
| MulTipeg™ 53 | In distribution | |
| MulTipeg™ 63 | In distribution | |
| MulTipeg™ 15 | In distribution | |
| MulTipeg™ 141 | In distribution | |
| MulTipeg™ 122 | In distribution | |
| MulTipeg™ 144 | In distribution | |
| MulTipeg™ 17 | In distribution | |
| MulTipeg™ 26 | In distribution | |
| MulTipeg™ 147 | In distribution | |
| MulTipeg™ 69 | In distribution | |
| MulTipeg™ 57 | In distribution | |
| MulTipeg™ 134 | In distribution | |
| MulTipeg™ 55 | In distribution | |
| MulTipeg™ 133 | In distribution | |
| MulTipeg™ 121 | In distribution | |
| MulTipeg™ 23 | In distribution | |
| MulTipeg™ 139 | In distribution | |
| MulTipeg™ 104 | In distribution | |
| MulTipeg™ 61 | In distribution | |
| MulTipeg™ 120 | In distribution | |
| MulTipeg™ 138 | In distribution | |
| MulTipeg™ 130 | In distribution | |
| MulTipeg™ 74 | In distribution | |
| MulTipeg™ 135 | In distribution | |
| MulTipeg™ 46 | In distribution | |
| MulTipeg™ 13 | In distribution | |
| MulTipeg™ 100 | In distribution | |
| MulTipeg™ 60 | In distribution | |
| MulTipeg™ 96 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Aseptico | Aseptico, Inc. | 40 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 26 |
| Woodpecker | Guilin Woodpecker Medical Instrument Co., Ltd. | 16 |
| DTE | Guilin Woodpecker Medical Instrument Co., Ltd. | 16 |
| Delfin2 | Intra-Lock International | 16 |
| Ultrapro TX Cordless | Ultradent Products Inc. | 13 |
| CanalPro | Coltene/Whaledent Gmbh & Co. KG | 12 |
| ChecQPEG | Dentis Co., Ltd. | 12 |
| EdgeApex HP™ | US Endodontics, LLC | 11 |
| Penguin RFA | Integration Diagnostics Sweden AB | 10 |
| Henry Schein | Henry Schein, Inc. | 9 |
| elements Connect | Meta Systems Co., Ltd. | 8 |
Showing 12 of 307. All products under Handpiece, Direct Drive, Ac-Powered
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.