NOBELREPLACE HEXAGONAL IMPLANT— 510(k) K073142
Substantially EquivalentNobel Biocare USA, LLC
FDA 510(k) clearance K073142 for NOBELREPLACE HEXAGONAL IMPLANT, Substantially Equivalent on 2008-01-11. Applicant: Nobel Biocare USA, LLC. Device class: 2.
Clearance details
- Applicant
- Nobel Biocare USA, LLC
- Product code
- Code DZE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3640
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Yorba Linda,, CA, US
Recent devices under product code DZE
view allMore clearances from Nobel Biocare USA, LLC
view all- K132749 — NOBELPROCERA OVERDENTURE BAR
- K132746 — NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION
- K110171 — NOBELPROCERA ZI ABUTMENT THOMMEN PLATFORMS
- K083100 — GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP
- K062566 — NOBELREPLACE TAPERED CONICAL CONNECTION
Adverse events under product code DZE
product code DZE- Death
- 28
- Injury
- 3,367,041
- Malfunction
- 19,958
- Other
- 13
- Total
- 3,387,040
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K073142
K-number listed on FDA's recall record- Z-0658-2022 — NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
- Z-2828-2020 — NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K073142.
Data sourced from openFDA. This site is unofficial and independent of the FDA.