S-53 INTRORAL DENTAL SYSTEM
Device Facts
| Record ID | K962979 |
|---|---|
| Device Name | S-53 INTRORAL DENTAL SYSTEM |
| Applicant | Del Medical Systems Corp. |
| Product Code | DZA · Dental |
| Decision Date | Sep 25, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.4130 |
| Device Class | Class 1 |
Device Story
S-53 Video Imaging System; intraoral video camera system. Captures visual images of oral cavity; displays images for practitioner review. Used in dental clinical settings. Facilitates patient communication and clinical documentation. Design and technology comparable to existing intraoral video systems.
Clinical Evidence
No clinical data provided; substantial equivalence based on design and technological similarity to legally marketed devices.
Technological Characteristics
Intraoral video imaging system; optical sensor technology; video output. Technical specifications comparable to predicate devices.
Regulatory Classification
Identification
An intraoral dental drill is a rotary device intended to be attached to a dental handpiece to drill holes in teeth to secure cast or preformed pins to retain operative dental appliances.
Predicate Devices
- Fuji Optical Systems-Dentacam
- New Image-Accucam
Reference Devices
- IDT
- Welch Allyn
- Dentsply
- Air Technologies
Submission Summary (Full Text)
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# Exhibit 9
## 510(k) Summary
DMS will provide a 510(k) Summary and allow for the "public" to request this information.
We have taken the terminology from the Reference Manual-"Premarket Notification 510(k): Regulatory Requirements for Medical Devices" (FDA 92-4158).
## Summary
Del Medical Systems feels the S-53 Video Imaging System is substantially equivalent to the Fuji Optical Systems-Dentacam and the New Image-Accucam and also to many legally marketed devices already in commercial distribution such as: IDT, Welch Allyn, Dentsply and Air Tecghnologies,, just to name a few.
The design of the S-53 is virtually identical to the comparative devices, which are listed and displayed in Exhibits 2 and 3. Since the design is comparable, technology virtually identical, the specifications very similar, and the intended use the same, DMS feels that these minor differences have no impact on the safe use and/or effectiveness of the device.
For information purposes and completeness, Del Medical Systems has also incorporated other legally marketed devices in this filing to illustrate the wide, general use of similar other devices. This wide use has led to the safe use of the device in many practitioner's hands.
K962979
SEP 25 1996
