(31 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 Astra 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 Astra's Microthread ST 4.0mm, 4.5mm, and 5.0mm Implants.
The provided text does not contain any information about acceptance criteria, device performance, or a study to prove the device meets acceptance criteria.
The document is a 510(k) Pre-Market Notification for a dental implant abutment. It primarily focuses on:
- Device Identification: Trade name, common name, classification, and product code.
- Predicate Device: Identifying a legally marketed device for comparison.
- Device Description: Materials, compatibility with implants.
- Intended Use: What the device is designed to do and for whom.
- Basis for Substantial Equivalence: Stating that the new device is substantially equivalent to a previously cleared device.
- FDA Correspondence: A letter from the FDA confirming receipt and review of the 510(k) and its determination of substantial equivalence.
- Indications for Use: Formal statement of how the device is intended to be used.
In the context of a 510(k) submission, "substantial equivalence" means the new device is as safe and effective as a legally marketed predicate device. This often relies on demonstrating similar technological characteristics and performance to the predicate, rather than an independent de novo study with acceptance criteria in the way a novel high-risk device might require.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving device performance from this document. It does not contain details on:
- Acceptance criteria table or reported device performance.
- Sample size, data provenance, number of experts, adjudication method for a test set.
- MRMC comparative effectiveness study or effect size.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Training set sample size or how its ground truth was established.
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Pre-market Notification Page - 000009 ----------------------------
JUL 2 2 2 2005 51652
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.
1. Applicant's Name and Address
Atlantis Components Inc. 25 First Street Cambridge, Massachusetts 02141 Telephone Number: 617-661-9799 Fax Number: 617-661-9063 Contact Person: Franklin Uyleman Manager of Quality and Regulatory Affairs
2. Name of Device
| Trade Name: | Atlantis™ Abutment for Astra 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 |
4. Description of the Device
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 Astra 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 Astra's Microthread ST 4.0mm, 4.5mm, and 5.0mm Implants.
న్. Intended Use of the Device
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.
6. Basis for Substantial Equivalence
The Atlantis™ Abutments for Astra 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 stylized eagle with three lines forming its body and head, and two wavy lines forming its legs. The eagle is encircled by the words "U.S. Department of Health and Human Services, USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 2 2005
Atlantis Components, Incorporated C/O Ms. Betsy A. Brown B.A. Brown & Associates 8944 Tamaroa Terrace Skokie, Illinois 60076
Re: K051652
Trade/Device Name: Atlantis™ Abutment for Astra Implant Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 20, 2005 Received: June 22, 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 requirements as set 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), please 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,
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. 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 1652
Device Name: Atlantis TM Abutment for Astra 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 X (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)
RBetz DDS for Dr. Susan Runner
510(k) Number. K091652
§ 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.)