(116 days)
Not Found
Not Found
No
The summary describes a dental operative unit that supplies utilities and serves as a base for tools, with no mention of AI or ML capabilities.
No
The device is described as a dental operative unit intended to supply utilities to and serve as a base for dental tools and accessories, rather than directly treating a condition or disease.
No
The "Intended Use / Indications for Use" states that the device is a dental operative unit intended to supply utilities and serve as a base for dental tools and accessories, rather than to diagnose conditions.
No
The intended use describes "dental operative units" which are physical devices that supply utilities and serve as a base for dental tools. This clearly indicates a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "dental operative unit" intended to "supply utilities to and serve as a base for dental tools and accessories." This describes a device used during a dental procedure, not a device used to test samples outside of the body to diagnose a condition.
- Lack of IVD Indicators: The provided text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes or markers
- Providing diagnostic information about a patient's health status
Therefore, the CCEI Vista, Satellite Mobile Unit, and Satellite Unit are dental equipment used for operative procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The CCEI Vista, Satellite Mobile Unit and Satellite Unit are dental operative units that are intended to supply utilities to and serve as a base for dental tools and accessories.
Product codes
EIA, KLC
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.
0
SECTION 5 – 510(k) SUMMARY
| Submission Correspondent: | Emergo Group, Inc. | AUG 25 2008 |
|---|---|---|
| Address: | 1705 S. Capital of Texas Hwy | |
| Suite 500 | ||
| Austin, TX 78746 | ||
| Phone: | (512) 327-9997 | |
| Fax: | (512) 327-9998 | |
| Contact: | Stuart R. Goldman | |
| Submission Sponsor: | Craftmaster Contour Equipment, Inc. | |
| PO Box 331345 | ||
| Ft. Worth. TX 76163-1345 | ||
| 800.475.9260 | ||
| 817.568.9260 | ||
| www.ccei.net | ||
| Date Prepared: | April 9, 2008 | |
| Trade Name(s): | 1. Vista |
- Satellite Mobile Unit
- Satellite Unit | |
| Common/Usual Name(s): | Unit, Operative Dental (primary)
Chair, Dental, With Operative Unit (secondary) | |
| Classification Name(s): | Dental Operative Unit and Accessories (primary)
Dental Chair and Accessories (secondary) | |
| Classification Number(s): | 872.6640 (primary)
872.6250 (secondary) | |
| Classification Panel: | Dental Devices | |
| CDRH Product Code: | EIA (primary)
KLC (secondary) | |
| Regulatory Class: | I | |
1
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Craftmaster Contour Equipment, Incorporated C/o Mr. Stuart R. Goldmen Senior Consultant Emergo Group, Incorporated 1705 South Capital of Texas Highway Suite 500 Austin, Texas 78746
AUG 2 5 2008
Rc: K081237
Trade/Device Name: Vista Satellite Mobile Unit Satellite Unit
Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: July 14, 2008 Received: July 15, 2008
Dear Mr. Goldmen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Mr. Goldmen
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Chiu S. Lin, Ph.D.
Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATION'S FOR USE
510(k) Number (if known): K081237
Device Name:
- l . Vista
-
Satellite Mobile Unit
-
Satellite Unit
Indications for Use:
The CCEI Vista, Satellite Mobile Unit and Satellite Unit are dental operative units that are intended to supply utilities to and serve as a base for dental tools and accessories.
Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Suza Runser
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: 1081237
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