Engler 25K Series Ultrasonic Inserts
by Engler Engineering Corp. 510(k)
Active
510(k) K122748
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK122748 | Date11 Jun 2013 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- ELC
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.4850
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Engler 25K Series Ultrasonic Inserts are ultrasonic scalers designed for dental use. These devices generate high-frequency vibrations to remove plaque and calculus from teeth surfaces during professional dental cleaning procedures.
These inserts are intended for use with magnetostrictive scaling devices operating at 25 kilohertz. They are classified as Class II devices under FDA regulations (872.4850) and were granted 510K clearance (K122748) as substantially equivalent to predicate devices. Supplied as single-use or reusable components depending on the specific insert model, they require compatibility with approved 25K ultrasonic dental handpieces.
Other devices from Engler Engineering Corp.
Questions
AI-generated answers, 19 Sep 2026
Are the Engler 25K Series Ultrasonic Inserts designed for single-use only, or can they be reused after cleaning and sterilization?
The Engler 25K Series Ultrasonic Inserts are available in both single-use and reusable configurations, depending on the specific model. The data does not specify which models fall into each category, so it’s important to verify the intended use for the particular insert you are considering. Reusable inserts would require proper cleaning, sterilization, and maintenance to ensure safety and performance.
What types of dental handpieces are compatible with these ultrasonic inserts, and how do I ensure proper pairing?
The Engler 25K Series Ultrasonic Inserts are designed exclusively for use with 25 kilohertz (25K) magnetostrictive ultrasonic dental handpieces. Compatibility is critical, so you must confirm that your handpiece operates at this frequency and is approved for use with these inserts. The manufacturer’s instructions should specify which handpieces are compatible, and improper pairing could damage the device or compromise performance.
How do I determine which specific model or variant of the Engler 25K Series Ultrasonic Inserts is right for my practice?
The Engler 25K Series includes multiple models, as indicated by the extensive list of registration numbers (e.g., 3038718579, 3002806577, etc.). These variants may differ in design, tip shape, or intended use (e.g., subgingival scaling, supragingival cleaning). To select the correct model, consult the manufacturer’s catalog or technical specifications, which likely categorize inserts by tip geometry or clinical application. Always match the insert to your practice’s specific scaling needs.
What regulatory pathway was followed for FDA clearance of these ultrasonic inserts, and what does that mean for my purchase?
The Engler 25K Series Ultrasonic Inserts received FDA 510(k) clearance (K122748) under the Traditional 510(k) Review pathway, with a decision code of SESE (Substantially Equivalent). This means the FDA determined the device is as safe and effective as a legally marketed