(44 days)
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No
The summary describes a material used for dental splinting and reinforcement, with no mention of AI or ML capabilities or related concepts like image processing or performance metrics associated with AI/ML.
No
The device is used for mechanical support and restoration (splinting, reinforcing,
matrix, space maintainer) of teeth, which are structural and functional aids rather than direct therapeutic interventions to treat disease.
No
The provided text describes uses for splinting and reinforcing dental structures, acting as a matrix, and a space maintainer. These are all therapeutic or supportive functions, not diagnostic.
No
The provided text describes the intended use of a physical dental material or device for splinting and reinforcing teeth and dentures. There is no mention of software, algorithms, or digital processing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described are all related to mechanical support and reinforcement of teeth and dental prosthetics within the mouth. This involves physical manipulation and application to the patient's anatomy.
- IVD Definition: In vitro diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
The described device operates directly on the patient's teeth and dental structures, not on specimens taken from the body. Therefore, it falls outside the scope of an IVD.
N/A
Intended Use / Indications for Use
Splinting periodontially involved and mobile teeth to prevent movement.
To reinforce full denture and partial denture repairs.
As a matrix between abutinent teeth for receiving a temporary replacement tooth.
As an aid in the reinforcament of temporary crowns and bridgework
As a space maintainer for orthodontically Involved teeth.
Product codes
ELS
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3890 Endodontic stabilizing splint.
(a)
Identification. An endodontic stabilizing splint is a device made of a material, such as titanium, intended to be inserted through the root canal into the upper or lower jaw bone to stabilize a tooth.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Orug Administration 9200 Corporate Boulevard Rockville MD 20850
K972985
24 SEP 97
Mr. Murray Gamberg Quality Systems Director Jeneric/Pentron, Incorporated 53 North Plains Industrial Road Wallingford, Connecticut 06492-0724
K972985 Re : Splint It™ Trade Name: Regulatory Class : II ELS Product Code: Dated: August 8, 1997 Received: August 11, 1997
Dear Mr. Gamberg:
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 Quality System Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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
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Page 2 - Mr. Gamberg
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.gov/cdrh/dsmamain.html".
Sincerely yours,
Clins. F/r
Timothy A. Ulatowski
Timothy A. Ulato Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enalosure
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510(k) Number (if known): K972985
Device Name: Splint-I(™
Indications for Use
Splinting periodontially involved and mobile teeth to prevent movement.
To reinforce full denture and partial denture repairs.
As a matrix between abutinent teeth for receiving a temporary replacement tooth.
As an aid in the reinforcament of temporary crowns and bridgework
As a space maintainer for orthodontically Involved teeth.
EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
(Division Sign-Off) Concurrence of SBRH-Office of Device Evaluation (ODE) Division of D and General Ho 510k Over-the-Counter Use _ CFR 801 (Optional Format 1/2/96)