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The document is a 510(k) summary for the HAPTITE Coating Implant System, a dental implant device manufactured by Dentis Co., Ltd. It provides detailed information about the device's specifications, including its materials, design, and intended use for supporting dental restorations in partially or fully edentulous patients. The document also compares the HAPTITE system to predicate devices, demonstrating its substantial equivalence in terms of design and performance. Additionally, it outlines regulatory compliance and testing results that affirm the device's safety and effectiveness.

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What is the downside of dental implants?

A major disadvantage of dental implants is that they take a long time to heal. To start, our dentist must first ensure you have enough bone mass in your jaw to have the implants placed in the first place. If you dont, we need to give you a bone graft surgery.

What is the best age for dental implants?

So when is the right age for an implant? Depends on the patient, but many people should try to avoid placing anterior implants at the age of 18. These studies show that for some people, the best long term esthetics will be achieved if the patient waits until the age of 25 or 30.

Who should not have dental implants?

If you regularly or subconsciously grind teeth, have uncontrolled diabetes, gum disease or jaw irradiation following a cancer diagnosis, these situations dont bode well for dental implants. Essentially, these conditions must first be dealt with or controlled to ensure the best possible outcome for implant restoration.

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How common are dental implants?

Pioneered about 50 years ago, dental implants have grown in popularity since the 1970s as an alternative to dentures or bridges to replace unhealthy or missing teeth. Although only 6% of Americans have implants now, by 2026 that number is set to grow to 23%.

Are dental implants safe?

Dental implants can docHubly improve the quality of life and the health of a person who needs them. However, complications may sometimes occur. Complications can occur soon after dental implant placement or much later. Some complications result in implant failure (usually defined as implant looseness or loss).

Are dental implants high risk?

Takeaway. Dental implants are considered safe in many cases. Factors that affect how successful your dental implants are include your overall health, oral health, age, and lifestyle habits.

Dentis Co - accessdata fda 2025

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