Straumann TLX Novaloc and Cementable Abutments
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K203355 FDA 510(k)
- FDA Product Code
- NHA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3630 FDA 510(k)
- Regulation Number
- 872.3630 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Straumann TLX Novaloc and Cementable Abutments are dental implant prosthetic components designed for use in fixed and removable prosthodontics. Novaloc abutments feature a carbon-based retentive coating for securing full-arch overdentures via snap-on attachments, while cementable abutments support conventional crowns and bridges. These components are engineered to interface with Straumann dental implants, providing stable connections for various prosthetic restorations.
These abutments are supplied as single-use, sterile components intended for surgical use in dental offices and clinics. The Novaloc abutments incorporate a durable carbon coating and PEEK matrices, while cementable variants require cement fixation. The device carries FDA 510(k) clearance under the Dental advisory committee category, with model-specific identifiers such as 07630031746849 and catalog number 037.1100. Storage and handling must comply with standard sterile implant protocols.
Frequently asked questions
What are Straumann TLX Novaloc and Cementable Abutments used for?
These abutments are designed for dental implant prosthodontics, serving two primary purposes: Straumann TLX Novaloc abutments use a carbon-based retentive coating to secure full-arch overdentures via snap-on attachments, ideal for removable prosthetics. Cementable abutments, on the other hand, are intended for conventional crowns and bridges, requiring cement fixation for stability. Both are engineered to interface seamlessly with Straumann dental implants, ensuring durable connections for various prosthetic restorations.
Are Straumann TLX Novaloc and Cementable Abutments single-use or reusable?
These abutments are supplied as single-use, sterile components specifically intended for surgical use in dental offices and clinics. This design ensures patient safety and sterility, as each abutment is meant to be used once and discarded after implantation. Reuse is not recommended or supported by the manufacturer.
How should Straumann TLX Novaloc and Cementable Abutments be stored?
Storage and handling must comply with standard sterile implant protocols to maintain integrity and sterility. The manufacturer recommends adhering to best practices for sterile dental implants, such as keeping the components in their original packaging until immediately before use and storing them in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow the instructions provided in the packaging for optimal preservation.
What distinguishes the Novaloc abutments from the cementable variants?
The key distinction lies in their design and application: Novaloc abutments feature a durable carbon-based retentive coating and PEEK matrices, enabling them to secure full-arch overdentures via snap-on attachments. This makes them ideal for removable prosthodontics. In contrast, cementable abutments lack this coating and rely on traditional cement fixation, making them suitable for conventional crowns and bridges. Both are compatible with Straumann implants but serve different prosthetic needs.
What model or catalog numbers identify these abutments?
The Straumann TLX Novaloc and Cementable Abutments are identified by specific model and catalog numbers for clarity and ordering purposes. The model-specific identifier for these abutments includes 07630031746849, while the catalog number is 037.1100. These identifiers help ensure the correct components are selected for use with Straumann dental implants.
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. Sources consulted: Straumann® Novaloc®, Straumann TLX Novaloc and Cementable Abutments, DEVICE: Straumann TLX Novaloc and Cementable Abutments (07630031746849)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K203355 | Class II | Active |
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Manufacturer
- Manufacturer
- Institut Straumann AG
Sources (1)
- FDA 510(k) K203355 24 fields · synced Oct 1, 2026