NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION— 510(k) K132746
Substantially EquivalentNobel Biocare USA, LLC
FDA 510(k) clearance K132746 for NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION, Substantially Equivalent on 2014-01-30. Applicant: Nobel Biocare USA, LLC. Device class: 2.
Clearance details
- Applicant
- Nobel Biocare USA, LLC
- 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
- Yorba Linda,, CA, US
Recent devices under product code NHA
view allMore clearances from Nobel Biocare USA, LLC
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 K132746
K-number listed on FDA's recall record- Z-1677-2021 — NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s2 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics Material Number: 77339
- Z-1678-2021 — NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿s3 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77352
- Z-1679-2021 — NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s4 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77363
- Z-1680-2021 — NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s4 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77364
- Z-1681-2021 — NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s6 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77387
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132746.
Data sourced from openFDA. This site is unofficial and independent of the FDA.