Plasticeph
510(k) K810538
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK810538 | Date29 Apr 1981 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- EAG
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.1830
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Plasticéph is a dental cephalometer, a radiographic device used to capture lateral cephalometric images of the skull and facial structures. It is designed to assist in orthodontic assessment, treatment planning, and monitoring by providing precise measurements of craniofacial anatomy. These images are essential for evaluating skeletal relationships, dental alignment, and growth patterns in patients. The device falls under the classification of a Class II medical device, requiring premarket notification under FDA regulations.
The Plasticéph is supplied as a reusable dental instrument and is intended for use in clinical settings such as dental offices and orthodontic practices. It is not sterile upon receipt and must be cleaned and sterilized before use to ensure patient safety. The device adheres to FDA clearance (510(k) K810538) and is categorized under product code EAG, reflecting its role in dental radiography. Storage should follow manufacturer guidelines to maintain functionality and compliance with regulatory standards.
Questions
AI-generated answers, 1 Oct 2026
What is the Plasticéph used for in orthodontic treatment?
The Plasticéph is a dental cephalometer designed to capture detailed lateral cephalometric images of the skull and facial structures. These images are critical for orthodontists to evaluate skeletal relationships, dental alignment, and growth patterns in patients, enabling accurate treatment planning and monitoring throughout orthodontic care.
Is the Plasticéph supplied sterile, and how should it be prepared for use?
The Plasticéph is not sterile upon receipt. It is classified as a reusable dental instrument, so it must be thoroughly cleaned and sterilized before each use to ensure patient safety and maintain device integrity. Follow the manufacturer’s guidelines for sterilization to comply with clinical and regulatory standards.
What regulatory approval does the Plasticéph hold, and how is it classified?
The Plasticéph holds FDA clearance under 510(k) number K810538, classified as a Class II medical device. This clearance was granted through a traditional 510(k) review process, with a decision of substantial equivalence to a predicate device, affirming its safety and effectiveness for dental radiography applications.
How should the Plasticéph be stored to ensure functionality and compliance?
The Plasticéph should be stored according to the manufacturer’s instructions to preserve its functionality and ensure compliance with regulatory standards. Proper storage conditions help maintain the device’s accuracy and longevity, particularly in clinical settings where it is used for precise radiographic imaging.
What distinguishes the Plasticéph from other cephalometers in the market?
The Plasticéph is uniquely identified by its FDA-cleared model (K810538) and its role as a reusable dental cephalometer for lateral cephalometric imaging. Its design supports orthodontic assessment by providing precise measurements of craniofacial anatomy, differentiating it from other devices in the market by its specialized use in dental radiography.