Straumann Healing Abutments, Healing Caps, Closure Screws
510(k) K130808
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK130808 | Date28 Jun 2013 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- NHA
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3630
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Straumann Healing Abutments, Healing Caps, and Closure Screws are dental components designed for use in implantology. These components facilitate transmucosal healing by enabling soft tissue sculpturing around dental implants during the healing phase, typically in a one-stage surgical procedure. The healing caps and abutments are placed directly at the implant site, allowing soft tissue to be sutured around them without covering the implant, thereby reducing the need for a second surgical intervention. This approach supports predictable osseointegration and tissue integration.
These components are supplied as part of a dental implant system and are intended for intermediate use in clinical settings. The healing abutments and caps are non-sterile and require sterilization prior to use, adhering to standard dental sterilization protocols. They are classified under product code NHA and have received FDA clearance via a 510(k) submission (K130808) under the Dental advisory committee. Sizes and configurations are standardized for compatibility with Straumann implant systems, and storage should follow manufacturer guidelines to maintain integrity.
Other devices from Straumann USA
Questions
AI-generated answers, 1 Oct 2026
What is the purpose of Straumann Healing Abutments, Healing Caps, and Closure Screws in implantology?
These components are designed to facilitate transmucosal healing in dental implant procedures, specifically during the one-stage surgical process. By placing the healing caps and abutments directly at the implant site, soft tissue can be sutured around them without covering the implant itself. This approach minimizes the need for a second surgical intervention, promoting predictable osseointegration and tissue integration.
Are Straumann Healing Abutments, Healing Caps, and Closure Screws sterile when supplied?
No, these components are supplied as non-sterile. They must be sterilized prior to use following standard dental sterilization protocols to ensure safety and efficacy in clinical settings.
How are these components supplied and what sizes are available?
The Straumann Healing Abutments, Healing Caps, and Closure Screws are part of a dental implant system and are intended for intermediate use in clinical environments. Sizes and configurations are standardized to ensure compatibility with Straumann implant systems, but specific dimensions should be referenced in the manufacturer’s documentation for precise selection.
What storage guidelines should be followed for Straumann Healing Abutments, Healing Caps, and Closure Screws?
To maintain the integrity of these components, storage should adhere strictly to the manufacturer’s guidelines. Proper storage conditions help preserve their functionality and ensure they remain suitable for use in implant procedures.
What regulatory clearance does Straumann Healing Abutments, Healing Caps, and Closure Screws hold?
These components have received FDA clearance through a 510(k) submission (K130808) under the Dental advisory committee, classified under product code NHA. The clearance was granted as substantially equivalent to a predicate device.