Cleared Abbreviated

K260569 - DB 4000 High Impact Denture Base (FDA 510(k) Clearance)

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K260569 · Carbon, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
103d
Days
Class 2
Risk

K260569 is an FDA 510(k) clearance for the DB 4000 High Impact Denture Base. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Carbon, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on June 2, 2026 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Carbon, Inc. devices

Submission Details

510(k) Number K260569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2026
Decision Date June 02, 2026
Days to Decision 103 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 127d · This submission: 103d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Consultant

Nilo Medical Consulting Group, LLC
Michael Nilo

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EBI Resin, Denture, Relining, Repairing, Rebasing

All 329
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K260569.
Denture Base
K260376 · Shandong Huge Dental Material Corporation · May 2026
LuxCreo Flexible Partial Denture Resin
K253365 · LuxCreo, Inc. · Nov 2025
TERA HARZ Hard Denture (THD-C-500)
K253681 · Graphy, Inc. · Nov 2025
UltraPrint-Dental Denture UV
K253324 · Guangzhou Heygears IMC., Inc. · Nov 2025
Freeprint® denture flex
K252430 · Detax GmbH · Oct 2025
DENTURE SOFT EX (Pink set)
K252035 · Kamemizu Chemical Industry Co., Ltd. · Sep 2025