Denture Adjustment Kit
510(k) K820685
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK820685 | Date9 Apr 1982 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- EBO
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3570
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Denture Adjustment Kit is a dental device classified under the Denture Repair Kit nomenclature, designed for modifying and fitting dentures to improve comfort, stability, and occlusion. It includes tools and materials to adjust denture bases, reline surfaces, or repair minor structural issues without requiring full relining or replacement.
This kit is intended for use by dental professionals in clinical settings and is supplied as a non-sterile, single-use or reusable toolset depending on components (e.g., disposable reline materials versus reusable adjustment instruments). It adheres to FDA regulation 872.3570 under the Dental advisory committee and holds a Traditional 510(k) clearance (K820685) with a Substantially Equivalent determination. Components may include files, sanding discs, and reline materials, with sizes and quantities specified in the product code EBO.
Questions
AI-generated answers, 19 Sep 2026
What specific adjustments can the Denture Adjustment Kit make to dentures, and how does it differ from a full reline or replacement?
The Denture Adjustment Kit is designed for modifying and fitting dentures to enhance comfort, stability, and occlusion by addressing minor issues like adjusting denture bases or relining surfaces. Unlike a full reline or replacement—which involves reshaping the entire denture base—the kit focuses on targeted fixes using tools such as files, sanding discs, and reline materials. This allows dental professionals to make precise corrections without requiring extensive lab work or patient discomfort from a complete refit.
Is the Denture Adjustment Kit intended for single-use or reusable applications, and which components are disposable?
The kit includes both single-use and reusable components: disposable reline materials are intended for one-time use, while tools like files and sanding discs are designed for reuse. This dual-use approach ensures hygiene for patient-facing materials while maintaining cost-effectiveness for the reusable instruments. Always follow manufacturer guidelines for sterilization or disposal of reusable tools between patients.
What regulatory pathway was followed for FDA clearance, and how does this classification impact its use in clinical settings?
The Denture Adjustment Kit received a Traditional 510(k) clearance (K820685) under FDA regulation 872.3570, with a Substantially Equivalent determination by the Dental (DE) Advisory Committee. This classification means it was deemed comparable to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness standards for dental repair kits. Clinically, this clearance confirms its suitability for use by dental professionals in modifying dentures as described, adhering to established dental practices.
Are there different sizes or models available in the Denture Adjustment Kit, and how are they specified?
The kit is categorized under product code EBO, which encompasses multiple registration numbers (e.g., 1528710, 2241860) but does not specify distinct sizes or models in the provided data. Typically, such kits may include varying quantities of tools or reline materials, but exact sizing or model variations would require consulting the manufacturer’s documentation or catalog. Always verify compatibility with your practice’s common denture types before purchase.