Cleared Traditional

K261956 - Dental Barriers and Sleeves (AB0006)

K261956 is an FDA 510(k) clearance for Dental Barriers and Sleeves (AB0006), manufactured by ANI Co., Ltd.. The device is a Class 2 Dental device with product code PEM cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K261956 · ANI Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
89d
Days
Class 2
Risk

K261956 is an FDA 510(k) clearance for the Dental Barriers and Sleeves (AB0006). Classified as Dental Barriers And Sleeves (product code PEM), Class II - Special Controls.

Submitted by ANI Co., Ltd. (Suwon-Si, Gyeonggi-Do, KR). The FDA issued a Cleared decision on September 8, 2026 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 878.4370 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all ANI Co., Ltd. devices

FDA 510(k) Submission Details - K261956

510(k) Number K261956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2026
Decision Date September 08, 2026
Days to Decision 89 days
Submission Type Traditional
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
39d faster than avg
Panel avg: 128d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PEM Device Classification - Class 2, Special Controls

Product Code PEM Dental Barriers And Sleeves
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
Definition Intended To Serve As A Disposable Barrier For Dental Instruments To Reduce The Risk Of Cross Contamination Between Dental Patients.
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

JNM KOREA CO.,Ltd
Bobae Jung

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 - PEM Dental Barriers And Sleeves

All 16
Devices cleared under the same product code (PEM) and FDA review panel - the closest regulatory comparables to K261956.
Hygienic Protective Bite Cover (2207-010-50)
K262073 · D?rr Dental SE · Sep 2026
Dental Barrier and Sleeves
K250735 · Fomed Industries, Inc. · Jun 2025
Dental Barrier and Sleeves
K250606 · Yueying Medical Instruments (Langfang) Co., Ltd. · May 2025
Dental Barrier and Sleeves
K242435 · Wellmed Dental Medical Supply Co., Ltd. · Oct 2024
Dental Barrier and Sleeves
K233918 · Yongqing Huaguan Dental Instruments Factory · May 2024
Disposable Barrier Sleeves
K220662 · Premium Plus (Dongguan) Limited · May 2022