DENTAL IMPLANT— 510(k) K992937

Clearance details

Applicant

Nobel Biocare Uas, Inc.

Product code

Code DZE

Device class

Class 2

Regulation

21 CFR 872.3640

Advisory panel

Dental

Date received

1999-08-31

Decision date

2000-02-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Yorba Linda, CA, US

• K260463 — ZEROS Dental Implant System2026-08-19
• K251188 — UNIQA® Dental Implants System2026-06-25
• K250806 — Dental Implant System2026-06-18
• K251232 — MegaGen Zygoma Dental Implant System2026-06-18
• K260006 — INOSS System2026-06-17

• K050444 — NOBELREPLACE ADAPTER, MODEL 324122005-07-07
• K042658 — PROCERA ABUTMENT BRANEMARK, MODELS 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-60042004-10-20
• K041661 — NOBEL BIOCARE ENDOSSEOUS IMPLANTS2004-08-26
• K041876 — NOBELDIRECT OD IMPLANT2004-08-20
• K041312 — NOBELRONDO DENTAL CERAMIC-ALUMINA2004-07-23

Death

28

Injury

3,367,041

Malfunction

19,958

Other

13

Total

3,387,040

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2314-2016 — FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.Class II·Terminated·Medtronic Navigation, Inc.·20160718

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K992937.