Identifiers
- 510(k) Number
- K090020 FDA 510(k)
- FDA Product Code
- MUH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.1800 FDA 510(k)
- Regulation Number
- 872.1800 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Bel-Cypher Model Y977 is an X-Ray, Extraoral Source, Digital System designed for dental imaging. It generates radiographic images of the dento-maxillofacial region, including teeth, jaws, and oral structures, to aid in dental examination and diagnosis of associated pathologies.
This device is intended for use in dental settings and has received FDA 510(k) clearance under the Traditional pathway. It is classified as Class II under the regulation number 872.1800, with a MUH product code. The system is supplied as a reusable medical device and is intended for professional use only, adhering to electrical safety standards (Type B applied part). No information regarding sterility or single-use is provided.
Frequently asked questions
What is the primary use of the Bel-Cypher Model Y977 in a dental practice?
The Bel-Cypher Model Y977 is an X-Ray, Extraoral Source, Digital System specifically designed for dental imaging. It captures radiographic images of the dento-maxillofacial region, including teeth, jaws, and oral structures, to assist in dental examinations and help diagnose associated pathologies. This makes it ideal for capturing detailed images of hard-to-reach areas in the mouth.
Is the Bel-Cypher Model Y977 intended for single-use or reusable applications?
The Bel-Cypher Model Y977 is explicitly described as a reusable medical device. It is intended for professional use only and must be maintained according to manufacturer guidelines to ensure safety and performance. No information regarding single-use or sterility is provided, so proper cleaning and disinfection protocols must be followed.
What regulatory pathway was followed for the FDA clearance of the Bel-Cypher Model Y977?
The Bel-Cypher Model Y977 received FDA clearance under the Traditional 510(k) pathway, which means it was determined to be substantially equivalent to a legally marketed device. The clearance was granted on March 13, 2009, and the device is classified as Class II under regulation number 872.1800 with a product code of MUH.
What electrical safety standards does the Bel-Cypher Model Y977 adhere to?
The Bel-Cypher Model Y977 adheres to electrical safety standards classified as Type B applied part. This classification ensures that the device meets specific safety requirements for electrical medical devices, reducing risks associated with electrical hazards during use.
How would I determine if this device is compatible with my practice’s existing imaging systems?
The Bel-Cypher Model Y977 is a digital extraoral X-Ray system, so compatibility depends on whether your practice’s imaging software or network infrastructure supports digital radiography integration. While the device itself is designed for dental imaging, you should consult the manufacturer’s documentation or technical support to confirm compatibility with your specific imaging workflows and software.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BEL-CYPHER, MODEL Y977 (K090020) — FDA 510 (k) | Innolitics, 510(k) Premarket Notification, PDF Bel-Cypher - dental.belmont.ca, PDF Bel-Cypher Pro
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K090020 | Class II | Active |
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Manufacturer
- Manufacturer
- Takara-Belmont Co., Ltd.
Sources (1)
- FDA 510(k) K090020 24 fields · synced Sep 19, 2026