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This looks like a summary of a 510(k) submission for a medical device called "Dentatus MTI™ Anchor Post," which is an endodontic splint.
However, the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria. The document focuses on:
- Classification and identification of the device.
- A brief literature review asserting the safety and effectiveness of endodontic splints in general, not specifically the Dentatus MTI™ Anchor Post through a dedicated study.
- Substantial equivalence claims to pre-amendment devices and previously cleared devices, which is a regulatory pathway that often bypasses the need for new, extensive clinical studies if a device is sufficiently similar to existing ones.
- Technology details confirming it uses established materials and manufacturing methods.
Therefore, I cannot populate the table or answer your specific questions with the information provided. The document explicitly states: "Endodontic splints made of titanium or titanium alloy have V. been proved safe and effective through the years," implying reliance on general historical use and existing literature rather than a new study for this specific device.
If you have a different document that details acceptance criteria and performance studies for the Dentatus MTI™ Anchor Post, please provide that.
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XIII. SAFE MEDICAL DEVICES ACT SUMMARY OF SAFETY AND EFFECTIVENESS DATA. (Separate Page)
- I. Classification Name and Number: Endodontic Splint (76ELS)
- II. Common/Usual Name: Dental Anchor Post, titanium or titanium alloy.
- III. Proprietary Name: Dentatus MTI™ Anchor Post.
- IV. Classification: These devices were classified by the Dental Devices Panel (Title 21 CFR 872.3890.
- Brief Literature Review: Endodontic splints made of titanium or titanium alloy have V. been proved safe and effective through the years. A Medline literature search under endodontic-splint, or anchor, produced 32 pertinent articles. These were reviewed and summarized showing that this is not an active research field. The literature summarized showed that the endodontic splint is an old, well-known dental device with a broad area of safe and effective uses.
- VI. Substantial Equivalence: The Dentatus products are substantially equivalent to the pre-amendment devices classified under CFR 872.3890, to many endodontic splints manufactured before May 28, 1976, and to devices cleared by the 510(k) process such as the Biotechnics, Inc.,"Radicular Bio-Ceramic Pin," cleared under K-834363 and assigned the code ELS.
- VII. Technology: These devices are manufactured from the titanium materials proved effective by the above summarized years of clinical usage, may be sterilized by the standard methods including radiation or ethylene oxide and autoclaving in the dental office, and are constructed according to methods in the cited substantially equivalent products. Thus, they involve no new types of technology and no new technological questions.
- The "510(k) Substantial Equivalence Decision-Making Process VIII. Decision Tree: (Detailed)" from ODE Guidance Memo #86-3 was followed.
End of Summary
18b
§ 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.