Straumann Ceramic Healing Abutments
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Straumann CI RD Ceramic Healing Caps FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Ceramic Healing EUDAMEDCI RD Healing Cap, Ø 5.2mm, H 4.5mm, ZrO2/Ti FDA UDI
- Model / Reference
- 032.057S EUDAMEDHealing Components FDA UDI
- Description
- CI RD Healing Cap, Ø 5.2mm, H 4.5mm, ZrO2/Ti FDA UDI
Identifiers
- Catalog Number
- 032.057S FDA UDI
- Primary DI / UDI-DI
- 07630031735706 EUDAMEDFDA UDI
- Basic UDI-DI
- 0763003170064QU EUDAMED
- 510(k) Number
- K192893 FDA 510(k)
- FDA Product Code
- NHA FDA 510(k)FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 872.3630 FDA 510(k)
- Regulation Number
- 872.3630 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Height — 4.5 Millimeter FDA UDIOuter Diameter — 5.2 Millimeter FDA UDI
The Straumann Ceramic Healing Abutments are dental abutments designed to support and connect dental prostheses to dental implants. These components are crafted from ceramic material, providing a biocompatible and aesthetically pleasing interface for peri-implant soft tissue healing and restoration.
These abutments are supplied sterile and intended for single-use in dental implantology procedures. They are classified under the product code NHA and comply with FDA 510(k) clearance under the Traditional pathway, with a decision of Substantially Equivalent. Manufactured by Institut Straumann AG, they are intended for use in controlled clinical settings, adhering to dental implant protocols and regulatory standards.
Frequently asked questions
Are Straumann Ceramic Healing Abutments reusable or intended for single-use in procedures?
These abutments are explicitly designed for single-use only, as stated in the manufacturer’s description. They are supplied sterile to ensure patient safety and clinical reliability, which aligns with best practices for dental implantology to prevent cross-contamination.
What materials are the Straumann Ceramic Healing Abutments made from, and why does that matter?
The abutments are crafted from ceramic material, which provides a biocompatible and aesthetically pleasing interface. This choice is particularly important for peri-implant soft tissue healing and restoration, as ceramic reduces the risk of metal sensitivity or allergic reactions while offering a natural appearance.
How are these abutments classified under FDA regulations, and what does that mean for clinical use?
They fall under FDA product code NHA and were cleared via the Traditional 510(k) pathway, determined to be *Substantially Equivalent* to a predicate device. This classification confirms their compliance with FDA standards for dental implant abutments, ensuring they meet safety and performance requirements for use in controlled clinical settings.
What storage or handling considerations should be taken into account for Straumann Ceramic Healing Abutments?
Since they are supplied sterile, they must be stored according to the manufacturer’s guidelines to maintain sterility until use. Proper packaging integrity and adherence to dental implant protocols are critical, as the abutments are intended for single-use in sterile procedures to prevent contamination.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K192893 | Class II | Active |
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Manufacturer
- Manufacturer
- Institut Straumann AG
Sources (3)
- FDA 510(k) K192893 24 fields · synced Sep 18, 2026
- FDA UDI bab72707-e6bd-402e-8051-a412af9b13c7 37 fields · synced May 30, 2026
- EUDAMED 3db3c251-0045-4e15-9975-f68a38e78675 61 fields · synced Jul 22, 2026