Rextar, Rextar LCD
510(k) K122016
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK122016 | Date1 Mar 2013 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EHD
- Device class
- Class II
- Regulation
- 21 CFR Part 872.1800
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The REXTAR, REXTAR LCD is a Unit, X-Ray, Extraoral With Timer, designed for dental use. It functions as a portable, extraoral X-ray system that produces diagnostic images using intraoral image receptors, intended for both adult and pediatric patients in dental settings.
This device is supplied as a reusable, non-sterile medical instrument and is classified as a Class II device under FDA regulation 872.1800. It is intended for use in dental offices by trained professionals and has received FDA 510(k) clearance (K122016) as substantially equivalent to predicate devices. The system operates as a mobile X-ray source and requires proper handling, storage, and maintenance in accordance with dental radiographic safety protocols.
Other devices from Meta Biomed, Inc.
Questions
AI-generated answers, 19 Sep 2026
Is the REXTAR X-ray system designed for single-use or reusable applications in a dental setting? Why does this matter?
The REXTAR is explicitly supplied as a reusable, non-sterile medical instrument. This distinction matters because reusable devices require proper cleaning, disinfection, and maintenance protocols to ensure safety and functionality between uses, whereas single-use devices eliminate these steps but are discarded after one use. Since it’s reusable, your practice must follow dental radiographic safety protocols and manufacturer guidelines for upkeep to maintain performance and compliance.
What types of patients can use the REXTAR, and how does its portability benefit dental professionals?
The REXTAR is designed for both adult and pediatric patients in dental settings. Its portable, extraoral X-ray system allows for flexibility in imaging, enabling use in various treatment areas (e.g., operatory, chairside) without requiring fixed equipment. This mobility is particularly useful for pediatric patients, who may be more comfortable with a mobile device, or for complex cases requiring repositioning.
How should the REXTAR be stored, and what considerations should be taken into account for long-term use?
While the data doesn’t specify exact storage instructions, the REXTAR is a reusable, non-sterile device intended for dental use, so it must be stored in a clean, dry environment to prevent contamination or damage. Proper handling and maintenance (e.g., regular calibration, part inspections) are critical for long-term reliability, as outlined in dental radiographic safety protocols. Avoid exposure to extreme temperatures or humidity, which could affect performance or safety.
What regulatory pathway was followed for FDA clearance, and how does this affect its use in dental practices?
The REXTAR received FDA 510(k) clearance (K122016) under the Traditional 510(k) Review pathway, demonstrating it is substantially equivalent to predicate devices. This clearance confirms it meets FDA safety and effectiveness standards for Class II devices (regulatory number 872.1800) and is intended for dental use by trained professionals. Practices must ensure staff are trained in its operation and comply with dental radiographic safety protocols to maintain compliance and patient safety.