Straumann Manufacturing, Inc.
FDA Regulatory Profile
Straumann Manufacturing, Inc. appears in FDA public data with 11 recalls, 4 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0455-2019, Class II) was initiated on October 2, 2018. Its most recent 510(k) clearance was granted on December 15, 2009.
Summary
- Total Recalls
- 11
- 510(k) Clearances
- 4
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0455-2019 | Class II | Neodent¿ GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prostheti | October 2, 2018 |
| Z-1695-2018 | Class II | Straumann¿ Emdogain 0.3 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.113 | March 23, 2018 |
| Z-1694-2018 | Class II | Straumann¿ Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099 | March 23, 2018 |
| Z-1696-2018 | Class II | Straumann¿ Emdogain 0.3 ml Multipack. Enamel Matrix Derivative. Article Number 075.114W | March 23, 2018 |
| Z-1693-2018 | Class II | Straumann¿ Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number 075.098W | March 23, 2018 |
| Z-1698-2018 | Class II | Straumann¿ Emdogain 0.7 ml Multipack. Enamel Matrix Derivative. Article Number 075.116W | March 23, 2018 |
| Z-1697-2018 | Class II | Straumann¿ Emdogain 0.7 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.115 | March 23, 2018 |
| Z-0958-2017 | Class II | Straumann Twist Drill PRO ¿4.2mm,long,41mm,SS-Non sterile. Dental implant accessory Article Numbe | November 23, 2016 |
| Z-0957-2017 | Class II | Straumann Drill 1, short, ¿ 2.2mm, l 33.0mm, SS-Non sterile. Dental implant accessory Article Numb | November 23, 2016 |
| Z-2535-2016 | Class II | Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP Article Number: 021.4512 | July 14, 2016 |
| Z-2534-2016 | Class II | Straumann Bone Level Implant, ¿ 4.1mm RC, SLA 10mm, TiZr, NTP Article Number: 021.4510 | July 14, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K092814 | STRAUMANN DENTAL ABUTMENTS | December 15, 2009 |
| K090260 | MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS | February 26, 2009 |
| K080239 | P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANENT COPINGS | April 30, 2008 |
| K070478 | P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (CAP) | September 20, 2007 |