510(k) K990846 ยท DZI Drill, Bone, Powered
AMORPHOUS DIAMOND COATED DRILL
| Applicant | Nobel Biocare Uas, Inc., Yorba Linda CA, US |
| Decision | Substantially Equivalent, Jun 10, 1999 |
| Received | Mar 15, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990846
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.