PROCERA PREPARABLE ABUTMENT SYSTEM— 510(k) K974150
Substantially EquivalentNobel Biocare Uas, Inc.
FDA 510(k) clearance K974150 for PROCERA PREPARABLE ABUTMENT SYSTEM, Substantially Equivalent on 1998-01-23. Applicant: Nobel Biocare Uas, Inc.. Device class: 2.
Clearance details
- Applicant
- Nobel Biocare Uas, Inc.
- Product code
- Code NHA
- Device class
- Class 2
- Regulation
- 21 CFR 872.3630
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westmont, IL, US
Recent devices under product code NHA
view allMore clearances from Nobel Biocare Uas, Inc.
view allAdverse events under product code NHA
product code NHA- Injury
- 1,270
- Malfunction
- 2,860
- Total
- 4,130
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 K974150
K-number listed on FDA's recall record- Z-1852-2020 — Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36662 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.
- Z-1853-2020 — Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36664 - - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for 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 K974150.
Data sourced from openFDA. This site is unofficial and independent of the FDA.