Drill, Bone, Powered
Regulation 872.4120
3510(k)s in 12 months (50 all time)
0recalls in 12 months (21 all time)
16recalls that name a 510(k)
Top companies in DZI
| Company | 510(k)s | Recalls |
|---|---|---|
| Nobel Biocare Usa Llc | 0 | 15 |
| Implant Innovations, Inc. | 0 | 5 |
| Mectron S.P.A. | 5 | 0 |
| Jedmed Instrument Co. | 4 | 0 |
| Satelec | 3 | 0 |
| Bonart Co., Ltd. | 2 | 0 |
| Dmetec.Co., Ltd. | 2 | 0 |
| Dong IL Technology , Ltd. | 2 | 0 |
| Implant Direct Sybron Manufacturing, LLC | 2 | 0 |
| Linvatec Corp. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 19, 2020 | Nobel Biocare Usa Llc Implant Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above. Terminated |
DZI | K990846 |
| Feb 19, 2020 | Nobel Biocare Usa Llc Dense Bone Drill WP 5x13 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement. Terminated |
DZI | K990846 |
| Feb 19, 2020 | Nobel Biocare Usa Llc Dense Bone Drill NP 3.5x16 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement. Terminated |
DZI | K990846 |
| Feb 19, 2020 | Nobel Biocare Usa Llc Drill Tapered 6.0 6x8 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement. Terminated |
DZI | K990846 |
| Feb 19, 2020 | Nobel Biocare Usa Llc Drill Tapered WP 5x11.5 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement. Terminated |
DZI | K990846 |
| Feb 19, 2020 | Nobel Biocare Usa Llc Drill Tapered WP 5x10 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement. Terminated |
DZI | K990846 |
| Feb 19, 2020 | Nobel Biocare Usa Llc Drill Tapered RP 4.3x13 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants. Terminated |
DZI | K990846 |
| Feb 19, 2020 | Nobel Biocare Usa Llc Drill Tapered RP 4.3x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants. Terminated |
DZI | K990846 |
| Feb 19, 2020 | Nobel Biocare Usa Llc Drill Tapered RP 4.3x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants. Terminated |
DZI | K990846 |
| Feb 19, 2020 | Nobel Biocare Usa Llc Drill Tapered NP 3.5x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants. Terminated |
DZI | K990846 |
| Feb 19, 2020 | Nobel Biocare Usa Llc Drill Tapered NP 3.5x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants. Terminated |
DZI | K990846 |
| Feb 19, 2020 | Nobel Biocare Usa Llc Screw Tap Tapered WP Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants. Terminated |
DZI | K990846 |
| Feb 19, 2020 | Nobel Biocare Usa Llc Dense Bone Drill 6.0 6x16 mm Single-Pat- Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants. Terminated |
DZI | K990846 |
| Feb 19, 2020 | Nobel Biocare Usa Llc Drill Tapered NP 3.5x8 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants. Terminated |
DZI | K990846 |
| Jul 20, 2016 | Nobel Biocare Usa Llc Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit
Instructions for Use (IFU): "NobelGuide for NobelParallel Conical Connection", id # 2002 and Manual: Guided Surgery with NobelParall Terminated |
DZI | K990846 |
| Nov 16, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker Instruments 2.1 mm Cross-Cut Fissure Bur, carbide extended, sterile; REF 2296-101-621. Terminated |
DZI | K040369 |
| Jul 20, 2004 | Implant Innovations, Inc. Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labled as follows: 3i Implant Innovations, Inc., 4555 Riverside Drive, Palm Beach 33410 USA 56 Terminated |
DZI | None listed |
| Jul 20, 2004 | Implant Innovations, Inc. Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labled as follows: 3i Implant Innovations, Inc., 4555 Riverside Drive, Palm Beach 33410 USA 56 Terminated |
DZI | None listed |
| Jul 20, 2004 | Implant Innovations, Inc. Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labled as follows: 3i Implant Innovations, Inc., 4555 Riverside Drive, Palm Beach 33410 USA 56 Terminated |
DZI | None listed |
| Jul 20, 2004 | Implant Innovations, Inc. Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labled as follows: 3i Implant Innovations, Inc., 4555 Riverside Drive, Palm Beach 33410 USA 56 Terminated |
DZI | None listed |
| Jul 20, 2004 | Implant Innovations, Inc. Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labled as follows: 3i Implant Innovations, Inc., 4555 Riverside Drive, Palm Beach 33410 USA 56 Terminated |
DZI | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.