MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEM

K961704 · Dentatus USA , Ltd. · ELS · Jul 26, 1996 · Dental

Device Facts

• Record ID: K961704
• Device Name: MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEM
• Applicant: Dentatus USA , Ltd.
• Product Code: ELS · Dental
• Decision Date: Jul 26, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3890
• Device Class: Class 2
• Attributes: Therapeutic

Device Story

Dentatus MTI™ Anchor Post; titanium or titanium alloy dental anchor post; used for endodontic splinting/restoration; operated by dental professionals in clinical settings; provides structural support for dental restorations; utilizes established materials and designs consistent with pre-amendment endodontic splints.

Clinical Evidence

No clinical data; reliance on literature review of 32 articles confirming safety and effectiveness of titanium endodontic splints.

Technological Characteristics

Material: Titanium or titanium alloy. Sterilization: Radiation, ethylene oxide, or autoclave. Form factor: Dental anchor post. Technology: Traditional mechanical dental fixation; no new technology.

Indications for Use

Indicated for use as an endodontic splint or dental anchor post for dental restoration procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Radicular Bio-Ceramic Pin (K834363)

Submission Summary (Full Text)

{0}

JUL 26 1996
K961704

# 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.
V. Brief Literature Review: Endodontic splints made of titanium or titanium alloy have 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.
VIII. Decision Tree: The "510(k) Substantial Equivalence Decision-Making Process (Detailed)" from ODE Guidance Memo #86-3 was followed.

End of Summary

18b