# The Straumann Co.

- Location (FDA's records): Cambridge, MA
- FDA decisions: 15 (1992–2004): 14 510(k) clearances and 1 original PMA approval
- Names in FDA's records: The Straumann Co. (14); The Straumann Company (1)
- Product codes: DZE (8), JEY (1), DZL (1), GDM (1), LYC (1), NHA (1), OAT (1), NQA (1)
- Predicates its devices cite: 17 (1 its own); citations of its devices by later devices: 27 (1 its own)
- Recalls linked to its devices: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Nobelpharma USA, Inc.: 2 (https://510kreport.com/company/nobelpharma-usa)
- Synthes (Usa): 2 (https://510kreport.com/company/synthes-usa)
- Institut Straumann AG: 1 (https://510kreport.com/company/institut-straumann)
- Lifecore Biomedical, Inc.: 1 (https://510kreport.com/company/lifecore-biomedical)
- Interpore Cross Intl.: 1 (https://510kreport.com/company/interpore-cross-intl)
- Medtronic Sofamor Danek USA, Inc.: 1 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Geistlich Pharma AG: 1 (https://510kreport.com/company/geistlich-pharma)
- Bio-Interfaces, Inc.: 1 (https://510kreport.com/company/bio-interfaces)

## Firms that cite its devices most
- Institut Straumann AG: 8 (https://510kreport.com/company/institut-straumann)
- Straumann USA: 5 (https://510kreport.com/company/straumann-usa)
- Lifecore Biomedical, Inc.: 2 (https://510kreport.com/company/lifecore-biomedical)
- Northern Implants, LLC: 2 (https://510kreport.com/company/northern-implants)
- Dr. Ihde Dental AG Switzerland: 1 (https://510kreport.com/company/dr-ihde-dental-ag-switzerland)
- Straumann Manufacturing, Inc.: 1 (https://510kreport.com/company/straumann-manufacturing)
- Drm Research Laboratories, Inc.: 1 (https://510kreport.com/company/drm-research-laboratories)
- Implant Innovations, Inc.: 1 (https://510kreport.com/company/implant-innovations)

## Its most-cited devices
- K962023: Plastic Protection Healing Caps (1996), cited by 4
- K920768: Hollow Screw Implants 6MM, 14MM, 16MM (1992), cited by 4
- K955281: Endosseous Dental Implant & Accessories (1996), cited by 3
- K955369: Memfix (1996), cited by 3
- K960634: Titanium Healing Caps (1996), cited by 3
- K041070: Straumann Temporary Coping (2004), cited by 3

## Recent decisions
- K041070: Straumann Temporary Coping (Jul 23, 2004)
- K040646: Straumann Granules (May 3, 2004)
- K040469: The Straumann Ortho Implant System (Apr 30, 2004)
- K993862: Modus Sagittal Split Plate (Dec 29, 1999)
- P930021: Biora Emdogain (R) (Sep 30, 1996)
- K962023: Plastic Protection Healing Caps (Aug 15, 1996)
- K960634: Titanium Healing Caps (Jun 18, 1996)
- K955281: Endosseous Dental Implant & Accessories (Mar 15, 1996)

Source page: https://510kreport.com/company/straumann