(82 days)
The Atlantis Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations. The Atlantis™ Abutments for 3i Certain™ Implant and abutment screws are made from Titanium grade Ti-6A1-4V ELI (Meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with 3i Certain Standard Implants with 4.1mm, 5.0mm, 6.0mm diameters; the OSSEOTITE® XP Certain Implants with 5.0mm and 6.0mm diameters; and the OSSEOTITE® NT® Certain™ Implants with 4.0mm, 5.0mm and 6.0mm diameters.
The provided text describes a 510(k) premarket notification for a medical device called the Atlantis™ Abutment for 3i Certain™ Implant. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.
Therefore, the document does not contain information regarding:
- Acceptance criteria and reported device performance in a table. The summary focuses on equivalence to a predicate device rather than specific performance metrics against pre-defined acceptance criteria.
- A study that proves the device meets acceptance criteria. No specific study design, methodology, or results are presented that would demonstrate the device meeting particular performance targets.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance study.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
Instead, the document focuses on:
- Device Identification: Trade Name, Common Name, Classification Name, Regulation Number, Product Code.
- Predicate Device: Identification of the legally marketed device to which equivalence is claimed.
- Description of the Device: Material used (Titanium grade Ti-6A1-4V ELI), compatibility with various implant diameters, and its function as an abutment and abutment screw.
- Intended Use: As an accessory to an endosseous implant to support a prosthetic reconstruction in partially or completely edentulous patients, supporting single and multiple tooth prostheses in the mandible or maxilla, with cement-retained prostheses.
- Basis for Substantial Equivalence: Stating that the device is substantially equivalent in intended use, material, design, and performance to the predicate device cleared under K981858.
- Regulatory Outcome: FDA's determination of substantial equivalence, allowing the device to be marketed.
In summary, this document is a regulatory submission demonstrating equivalence, not a clinical or performance study report with specific acceptance criteria and detailed study results. Therefore, it does not provide the information requested in the prompt regarding acceptance criteria, study details, and ground truth establishment.
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Kostoll
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Pre-market Notification Page - 0000009
VII. SECTION 10 - 510(K) SUMMARY
This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR Part 807.92.
Applicant's Name and Address 1.
Atlantis Components Inc. 25 First Street Cambridge, Massachusetts 02141 617-661-9799 Telephone Number: 617-661-9063 Fax Number: 1 Contact Person: Franklin Uyleman Manager of Quality and Regulatory Affairs
2. Name of Device
| Trade Name: | Atlantis™ Abutment for 3i Certain™ Implant |
|---|---|
| Common Name: | Endosseous dental implant abutment |
| Classification Name: | Endosseous dental implant abutment |
| 21 CFR 872.3630 Product code NHA |
Legally Marketed Device to which Equivalence is claimed (Predicate Device) 3.
| Manufacturer | Device | 510(k) Number |
|---|---|---|
| Atlantis ComponentsInc. | Atlantis Abutment and AbutmentScrew | K981858 |
Description of the Device 4.
The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations.
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Pre-market Page - 000010 - - - - - - - - - - - - - - - -
Description of the Device (continued) 4.
The Atlantis™ Abutments for 3i Certain™ Implant and abutment screws are made from Titanium grade Ti-6A1-4V ELI (Meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with 3i Certain Standard Implants with 4.1mm, 5.0mm, 6.0mm diameters; the OSSEOTITE® XP Certain Implants with 5.0mm and 6.0mm diameters; and the OSSEOTITE® NT® Certain™ Implants with 4.0mm, 5.0mm and 6.0mm diameters.
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Intended Use of the Device న్న
The devices covered by this submission are abutments which are placed into a dental implant to provide support for a prosthetic reconstruction. The Atlantis Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
Basis for Substantial Equivalence 6.
The Atlantis™ Abutments for 3i Certain Implants are substantially equivalent in intended use, material, design and performance to the Atlantis Abutments cleared under K981858.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 2 2005
Atlantis Components, Incorporated C/O Betsy A. Brown B.A. Brown & Associates 8944 Tamaroa Terrace Skokie, Illinois 60076
Re: K051011
Trade/Device Name: Atlantis™ Abutment for 3i Certain™ Implant Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: April 20, 2005 Received: April 21, 2005
Dear Ms. Brown:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Brown
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and instills ( = = = = forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), nlease contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Aury Suleom for
Chiu Lin. Ph. B Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Pre-market Notification Page - 000205
Indications for Use
510(k) Number (if Known)_KOS 1011
Device Name: Atlantis ™ Abutment for 3i Certain™ Implant
Indication for Use:
The Atlantis Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
Prescription Use 8 (Part 21 CFR 801 SubpartD) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kbtz DVS for Dr. S. Runner
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K051011
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)