Acteon
Crest splitting: easy and controlled technique A thin crest is no more a barrier to place implants. The CS tips can smoothly enlarge the crest, one by one, avoiding the risks of bone…
Crest splitting: easy and controlled technique A thin crest is no more a barrier to place implants. The CS tips can smoothly enlarge the crest, one by one, avoiding the risks of bone breaking. This technique is faster and less exhausting for both practitioners and patients than the use of manual materials. Moreover the recommended irrigation flow and the hemostatic effect of the ultrasonics reduce bleeding. These conditions optimize the visibility of the surgical field.
2manufacturers in China registered for this device type
87catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangxi (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Guangdong Jinme Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 13 |
Record
| Listed by | Satelec, United States |
|---|---|
| FDA product code | DZI |
| Device type | Drill, Bone, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4120 |
| 510(k) | K091252 |
| Record published | 2016-09-24 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TIP BS4 II | In distribution | |
| TIP CS3 | In distribution | |
| TIP SL5 | In distribution | |
| TIP BS1 | In distribution | |
| TIP SL1 II | In distribution | |
| TIP TKW4 | In distribution | |
| TIP SL1 | In distribution | |
| PIEZOTOME PACK | In distribution | |
| TIP LC2R | In distribution | |
| PACK NEWTRON II PARO LED | In distribution | |
| TIP TKW5 II | In distribution | |
| TIP BS2L | In distribution | |
| TIP CE1 II | In distribution | |
| TIP LC2L II | In distribution | |
| TIP TKW1 II | In distribution | |
| PACK BS PZT 2 | In distribution | |
| TIP TKW3 | In distribution | |
| PIEZOTOME SOLO LED – US | In distribution | |
| TIP CE2 | In distribution | |
| TIP TKW3 II | In distribution | |
| KIT TIPS CE PZT 2 | In distribution | |
| SL INTRALIFT KIT PZT2 | In distribution | |
| TIP CS2 | In distribution | |
| KIT SINUS LIFT PZT 2 | In distribution | |
| KIT LC EXTRACTION PTZ 2 | In distribution | |
| TIP CS6 | In distribution | |
| TIP LC1 90° II | In distribution | |
| KIT INSERT BS PZT II | In distribution | |
| SL INTRALIFT KIT | In distribution | |
| MOTEUR IC2 LED | In distribution | |
| HANDPIECE PIEZOTOME 2 LED | In distribution | |
| TIP CE2 II | In distribution | |
| TIP BS2R | In distribution | |
| TIP LC2R II | In distribution | |
| TIP BS1 II | In distribution | |
| TIP TKW5 | In distribution | |
| TIP SL2 | In distribution | |
| TIP BS2R II | In distribution | |
| KIT ESSENTIAL 6 TIPS | In distribution | |
| TIP LC1 | In distribution | |
| TIP BS5 II | In distribution | |
| PIEZOTOME CUBE EMB USA | In distribution | |
| TIP NINJA | In distribution | |
| KIT SL SINUS LIFT | In distribution | |
| TIP TKW4 II | In distribution | |
| TIP NINJA II | In distribution | |
| PIEZOTOME SOLO LED US WO KIT | In distribution | |
| TIP LC2 II | In distribution | |
| TIP CE1 | In distribution | |
| TIP CS1 | In distribution | |
| TIP BS2L II | In distribution | |
| HANDPIECE CHIRURGICAL PIEZOTOME | In distribution | |
| KIT CREST SPLITTING PZTII LED | In distribution | |
| PIEZOTOME 2 CORD US | In distribution | |
| TIP CS5 | In distribution | |
| TIP SL3 II | In distribution | |
| KIT LC EXTRACTION | In distribution | |
| IMPLANT CENTER | In distribution | |
| MOTEUR I-SURGE+ | In distribution | |
| TIP LC1 II | In distribution | |
| TIP BS6 II | In distribution | |
| TIP CS4 | In distribution | |
| TIP TKW1 | In distribution | |
| TIP BS1RD II | In distribution | |
| PIEZOTOME 2 GP | In distribution | |
| TIP LC1 90° | In distribution | |
| TIP CE3 II | In distribution | |
| PIEZOTOME CUBE EMB CANADA | In distribution | |
| TIP SL2 II | In distribution | |
| TIP LC2 | In distribution | |
| TIP BS1L II | In distribution | |
| TIP SL3 | In distribution | |
| TIP TKW2 II | In distribution | |
| TIP SL5 II | In distribution | |
| TIP BS5 | In distribution | |
| TIP BS4 | In distribution | |
| TIP SL4 | In distribution | |
| IMPLANT CENTER 2 LED GP | In distribution | |
| TIP SL4 II | In distribution | |
| TIP TKW2 | In distribution | |
| TIP BS1S II | In distribution | |
| PACK LC EXTRACTION PZT 2 LED | In distribution | |
| TIP LC2L | In distribution | |
| KITS INSERT BS SL TKW | In distribution | |
| IMPLANT CENTER + PACK | In distribution | |
| TIP CE3 | In distribution | |
| PACK PIEZOTOME 2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Drill, Bone, Powered | Synthes Gmbh | 150 |
| Neoss Implant System | Neoss AB | 74 |
| Mectron | Mectron SPA | 48 |
| OneDrill Surgical Drill | Osseofuse International Inc. | 48 |
| Silfradent srl | Silfradent SRL | 45 |
| MatrixMANDIBLE | Synthes Gmbh | 31 |
| DIRECTguide™ Step Drill | Implant Direct Sybron Manufacturing LLC | 31 |
| DIRECTguide™ Guided Step Drill | Implant Direct Sybron Manufacturing LLC | 30 |
| Woodpecker | Guilin Woodpecker Medical Instrument Co., Ltd. | 28 |
| VarioSurg | Nakanishi Inc. | 22 |
| Nobel Biocare® | Nobel Biocare AB | 20 |
| Drill, Bone, Powered | Synthes (U.S.A.) LP | 19 |
Showing 12 of 265. All products under Drill, Bone, Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K091331 | 2009-12-11 |
| K091252 | 2009-07-22 |
| K060274 | 2006-05-01 |
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.