(218 days)
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Not Found
No
The provided 510(k) summary contains no information about the device description, image processing, AI/ML mentions, or performance studies, which are typical indicators of AI/ML technology in medical devices. The intended use suggests a simple soft tissue isolation and moisture prevention device.
No
The provided 'Intended Use / Indications for Use' describes functions like 'SOFT TISSUE ISOLATION' and 'MOISTURE PREVENTION', which are typically found in general medical devices used for procedures, rather than implying a therapeutic effect to treat or cure a disease or condition.
No
The intended use "SOFT TISSUE ISOLATION22 MOISTURE PREVENTION 2" describes a function related to surgical or procedural support, not the identification or diagnosis of medical conditions.
Unknown
The provided 510(k) summary is incomplete and lacks crucial information about the device description. Without knowing what the device is or how it functions, it's impossible to determine if it's software-only.
Based on the provided information, there is no indication that this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use "SOFT TISSUE ISOLATION22 MOISTURE PREVENTION 2" describes a function related to physical manipulation or protection of soft tissue, not the examination of specimens derived from the human body for diagnostic purposes.
- Lack of IVD-related information: The document is missing key information typically found in descriptions of IVD devices, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnostic claims or purposes
Therefore, based solely on the provided text, this device does not appear to be an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
SOFT TISSUE ISOLATION22 MOISTURE PREVENTION 2
Product codes
EIE
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6300 Rubber dam and accessories.
(a)
Identification. A rubber dam and accessories is a device composed of a thin sheet of latex with a hole in the center intended to isolate a tooth from fluids in the mouth during dental procedures, such as filling a cavity preparation. The device is stretched around a tooth by inserting a tooth through a hole in the center. The device includes the rubber dam, rubber dam clamp, rubber dam frame, and forceps for a rubber dam clamp. This classification does not include devices intended for use in preventing transmission of sexually transmitted diseases through oral sex; those devices are classified as condoms in § 884.5300 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.
0
Image /page/0/Picture/1 description: The image shows a logo with a stylized eagle design on the left. The eagle is composed of several curved lines, creating a sense of movement. To the right of the logo is the word "D" in a large, bold font. The logo is associated with the U.S. Department of Health and Human Services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 7 1998
Mr. William Grondin Director of Sales & Marketing Interdent Incorporated 2230 South Barrington Los Angeles, California 90064
K972775 Re: FastDam Trade Name: Regulatory Class: I Product Code: EIE February 16, 1998 Dated:
February 18, 1998
Dear Mr. Grondin:
Received:
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 reclassified 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 regulations 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 Ouality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Mr. Grondin
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
premarket notification" (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.qov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DFT
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Page of
| 510(k) Number (if known): | K972775 |
|---|---|
| Device Name: | FAST DAM |
Indications For Use:
SOFT TISSUE ISOLATION22 MOISTURE PREVENTION 2
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEBOED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sueerluser
..............................................................................................................................................................................
(Division Sign-Off) Division of Demal, I n Control and General Hospi 510(k) Number ..
Prescription Use_ (Pcr 21 CFR 801.109) OR
Over-The-Counter Use_
(Optional Formal 1-2-96)