Identifiers
- 510(k) Number
- K221972 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 Warantec Custom Abutment is a patient-specific dental abutment classified under the nomenclature for dental implant abutments. It is designed to support cement-retained crowns and bridges, fabricated from Ti-6Al-4V ELI titanium alloy (ASTM F136) for biocompatibility and structural integrity.
This abutment is manufactured using CAD/CAM technology based on a patient’s digital dental model, then produced at a Warantec-validated milling center. Supplied as a single-use, non-sterile device (unless sterilized by the user), it requires no additional regulatory approval beyond its FDA 510(k) clearance (K221972) under the Traditional pathway. Storage follows standard dental implant protocols, and its dimensions are determined by the patient-specific design.
Frequently asked questions
What materials is the Warantec Custom Abutment made from and why does that matter for dental use?
The Warantec Custom Abutment is made from Ti-6Al-4V ELI titanium alloy, which meets the ASTM F136 standard. This material is chosen for its excellent biocompatibility—minimizing adverse tissue reactions—and high structural integrity, ensuring durability and reliability in supporting cement-retained crowns and bridges. The ELI (Extra Low Interstitial) grade further reduces potential allergic responses, making it ideal for long-term dental implants.
How is the Warantec Custom Abutment customized for each patient, and what does that process involve?
The abutment is fabricated using CAD/CAM technology based on a patient’s digital dental model. Warantec’s validated milling center processes the design to create a precise, patient-specific fit. This ensures optimal alignment and function for cement-retained crowns or bridges, tailored to the individual’s anatomy without compromising the abutment’s structural integrity.
Is the Warantec Custom Abutment sterile when received, and what are the storage requirements?
The device is supplied as non-sterile by default, requiring the user to sterilize it before clinical use. Storage follows standard dental implant protocols, which typically involve keeping it in a clean, dry environment protected from contamination until sterilization. The patient-specific design doesn’t alter these general storage guidelines, as dimensions are determined post-manufacture.
Can the Warantec Custom Abutment be reused, or is it intended for single-use only?
The Warantec Custom Abutment is explicitly designed for single-use. While it is made from durable titanium alloy, its patient-specific nature and the risk of cross-contamination or altered fit after use make reuse impractical and unsafe. Clinicians should adhere to single-use protocols to ensure optimal outcomes and compliance with dental best practices.
What regulatory pathway was followed for FDA clearance, and does this affect how it’s used clinically?
The Warantec Custom Abutment received FDA clearance under the Traditional 510(k) pathway (K221972) with a decision code of SESE, indicating it was determined substantially equivalent to a predicate device. This clearance does not change its clinical use—it remains intended for supporting cement-retained crowns and bridges—but confirms its compliance with U.S. regulatory standards for dental implant abutments. No additional approvals are required beyond this clearance.
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: Warantec Custom Abutment (K221972) — FDA 510(k) | Innolitics, Dental Implant Abutment - warantec.com, K221972 FDA 510 (k) - Warantec Custom Abutment, Warantec Co., Ltd. FDA 510 (k) Products 2023
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221972 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- WARANTEC.Co., Ltd
- FDA Applicant
- Warantec Co., Ltd.
Sources (1)
- FDA 510(k) K221972 24 fields · synced Sep 19, 2026