# K990846: Amorphous Diamond Coated Drill

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare Uas, Inc.
- Decided: Jun 10, 1999 after 87 days
- Product code: DZI (Drill, Bone, Powered)
- Device class: 2
- Regulation: 21 CFR 872.4120
- Recalls of this device: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Nobel Biocare USA, Inc. Steri-Oss System Surgical Drill: named in the summary without a submission number

## Most influential descendants
- K071352: Ceradrill (2007), 0 descendants of its own

## Recalls of this device
- Mar 14, 2019 · Class II · Z-1304-2020: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during
- Mar 14, 2019 · Class II · Z-1305-2020: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during
- Mar 14, 2019 · Class II · Z-1323-2020: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during
- Mar 14, 2019 · Class II · Z-1307-2020: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during
- Mar 14, 2019 · Class II · Z-1313-2020: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during
- Mar 14, 2019 · Class II · Z-1310-2020: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during
- Mar 14, 2019 · Class II · Z-1312-2020: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during
- Mar 14, 2019 · Class II · Z-1314-2020: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during
- Mar 14, 2019 · Class II · Z-1315-2020: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during
- Mar 14, 2019 · Class II · Z-1303-2020: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during
- Mar 14, 2019 · Class II · Z-1311-2020: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during
- Mar 14, 2019 · Class II · Z-1308-2020: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during
- Mar 14, 2019 · Class II · Z-1309-2020: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during
- Mar 14, 2019 · Class II · Z-1306-2020: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during
- Jul 20, 2016 · Class II · Z-2375-2016: Incorrect drill protocol in the Instructions for Use (IFU)

## Indications for use
The intended use for this device is to cut into the maxilla or mandible to create an osteotomy for endosseous dental implant placement. The amorphous diamond coated drill design is intended to minimize corrosion and to increase longevity of the tool.

Source page: https://510kreport.com/device/K990846
Methodology: https://510kreport.com/methodology