MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVERDENTURE BARS— 510(k) K052648
Substantially EquivalentImplant Innovations, Inc.
FDA 510(k) clearance K052648 for MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVERDENTURE BARS, Substantially Equivalent on 2005-10-20. Applicant: Implant Innovations, Inc.. Device class: 2.
Clearance details
- Applicant
- Implant Innovations, 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
- Special
- Location
- Palm Beach Gardens, FL, US
Recent devices under product code NHA
view allMore clearances from Implant Innovations, 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 K052648
K-number listed on FDA's recall record- Z-0073-2021 — BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ
- Z-0074-2021 — BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4
- Z-0075-2021 — CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4
- Z-0076-2021 — CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5
- Z-0077-2021 — CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4
- Z-0078-2021 — CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5
- Z-0079-2021 — CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6
- Z-2140-2019 — CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
- Z-2141-2019 — CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IEDAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
- Z-2142-2019 — CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IIAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
- Z-2143-2019 — CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number ILDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
- Z-2144-2019 — CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number ILDAT3 - Product Usage:BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
- Z-1215-2014 — Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ , EDAZx and ILDExxx***BellaTek Zirconia Abutment Position Number: XX Abutment; Pilier; Abutment; Abutment; Pilastro; Pilar***Rx only***Non-sterile, Sterilize prior to use.***Biomet 3i Dental Iberica S.L.*** Biomet 3i Dental Abutments are intended for use as accessories to endosseous dental implants to support prostheses in edentulous or partially edentulous patients. These are intended for use to support single and multiple tooth prostheses.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K052648.
Data sourced from openFDA. This site is unofficial and independent of the FDA.