(84 days)
K932873, K964
Not Found
No
The provided text describes a standard dental delivery system and air abrasion system without any mention of AI or ML capabilities.
Yes
The device is described as operating dental handpiece attachments, suction instruments, and a Micadent air abrasion system that performs intra-oral air abrasion procedures for etching and preparing surfaces for composite restoration, which are therapeutic medical procedures.
No
Explanation: The device is described as a dental delivery system that operates dental handpiece attachments and suction instruments, and performs intra-oral air abrasion procedures. These are therapeutic and procedural functions, not diagnostic ones.
No
The device description clearly outlines a physical dental delivery system with hardware components like an air compressor, vacuum system, water supply, and handpiece attachments. It is not solely software.
Based on the provided information, the SEAC Advanced Dents System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The description of the SEAC Advanced Dents System clearly states its function is to operate dental handpiece attachments and suction instruments for intra-oral procedures. This involves working directly within the mouth, not analyzing samples taken from the body.
- The included Micadent air abrasion system is also used for intra-oral procedures like etching and preparing surfaces.
The device is a dental delivery system used for direct treatment and procedures within the oral cavity, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The SEAC Advanced Dents System is a self-contained dental delivery system with a built-in air compressor, vacuum system and water supply. It is designed operate dental handpiece attachments and suction instruments. The SEAC Advanced Dental System can also be upgraded to include a Micadent air abrasion system mounted inside the unit with the handpiece mounted in a holder along side the other handvises connections. The Micadent is used to perform intra-oral air abrasion procedures including etching and preparing surfaces for composite restoration,
Product codes
EIA
Device Description
The SEAC Advanced Dents System is a self-contained dental delivery system with a built-in air compressor, vacuum system and water supply. It is designed operate dental handpiece attachments and suction instruments. The SEAC Advanced Dental System can also be upgraded to include a Micadent air abrasion system mounted inside the unit with the handpiece mounted in a holder along side the other handvises connections. The Micadent is used to perform intra-oral air abrasion procedures including etching and preparing surfaces for composite restoration,
The SEAC Advanced Dental System is substantially similar in design and function as the SEAC Mobile Dental System manufactured by ASI Medical, Inc. The Micadent is manufactured by Medidenta and will be supplied to ASI as a completed product. The Micadent is substantially the same as it is provided and is attached to an accessory air line inside the SEAC unit for operation,
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intra-oral
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K932873, K964
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing right, with flowing lines suggesting movement or progress. The profiles are arranged in a way that they appear to be connected or overlapping. Encircling the image is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 1998
Mr. John W. McPeek President ASI Medical, Incorporated 14550 East Easter Avenue, Suite 1000 Englewood, Colorado 80112
Re : K974487 Seac Advanced Dental System - Model 2001, Trade Name: 2010 or Model 2020 Requlatory Class: I Product Code: EIA November 24, 1997 Dated: November 26, 1997 Received:
Dear Mr. McPeek:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been redical bevest in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895 ... A ... ................... substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Mr. McPeek
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to ene regaracion onetiisation" (21 CFR 807.97) . Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timo A IIIatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
1 Page
| Labels | Values |
|---|---|
| 510(k) Number (if known): | Applied 11/24/97 Existing 510 K's K932873 and K964 |
| Device Name: | Mobile Self-Contained Dental Unit |
| Indications For Use: |
Indications For Use:
DEC-
The SEAC Advanced Dents System is a self-contained dental delivery system with a built-in air compressor, vacuum system and water supply. It is designed operate dental handpiece attachments and suction instruments. The SEAC Advanced Dental System can also be upgraded to include a Micadent air abrasion system mounted inside the unit with the handpiece mounted in a holder along side the other handvises connections. The Micadent is used to perform intra-oral air abrasion procedures including etching and preparing surfaces for composite restoration,
The SEAC Advanced Dental System is substantially similar in design and function as the SEAC Mobile Dental System manufactured by ASI Medical, Inc. The Micadent is manufactured by Medidenta and will be supplied to ASI as a completed product. The Micadent is substantially the same as it is provided and is attached to an accessory air line inside the SEAC unit for operation,
(PLRASE DO NOT WELTE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NERIDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Susan Runner | |
| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K944418 7 |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use (Optional Format 1-2-96) |
|---|---|---|
| --------------------------------------- | ---- | ----------------------------------------------- |
| 02-12-1997 12:03 | 301 496 3002 | 96% P.02 |
|---|---|---|
| ------------------ | -------------- | ---------- |