(74 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.
This device is compatible with the following manufacturers' implant systems having an external hex with flat-to-flat dimensions of 2.7mm or greater: Nobel Biocare, 3i, Lifecore, Sterngold ImplaMed, Innova, and BioHorizons.
The Atlantis Abutment may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.
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™ Abutment in Zirconia is made of the biocompatible material, yttriastabilized tetragonal zirconia polycrystals (Y-TZP) (Meets ISO standards 6872 & 13356) and the abutment screw is made from Titanium grade Ti-6A1-4V ELI (Meets ASTM Standard F-136).
The provided document K052070 for the Atlantis™ Abutment in Zirconia does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity. This document is a 510(k) pre-market notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than on detailed performance studies with acceptance criteria typically associated with AI/ML-driven devices.
Here's why the requested information is not available in the provided text:
- Device Type: The Atlantis™ Abutment in Zirconia is a physical medical device (an endosseous dental implant abutment), not a software or AI/ML-driven device. Its evaluation for market clearance relies on material properties, mechanical testing (implied by meeting ISO and ASTM standards), biocompatibility, and substantial equivalence to a predicate device. Performance metrics like sensitivity or specificity are not applicable to this type of device in the same way they would be for diagnostic or AI-assisted systems.
- 510(k) Process: The 510(k) pathway for medical device clearance primarily requires the applicant to demonstrate that their new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing intended use, materials, design, and performance data from internal testing or adherence to recognized standards, rather than extensive clinical efficacy studies with specific performance acceptance criteria for diagnostic output.
Therefore, I cannot provide a table of acceptance criteria and reported device performance in the context of the input document, nor can I answer the questions related to sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies, as these concepts are not addressed for this particular device in this regulatory submission.
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OCT 1 4 2005
Pre-market Notification Page - 000009 - - - - - - - - - - - - - - - - -
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 in Zirconia |
|---|---|
| Common Name: | Endosseous dental implant abutment |
| Classification Name: | Endosseous dental implant abutment21 CFR 872.3630 Product code NHA |
3. Legally Marketed Device to which Equivalence is claimed (Predicate Device)
| Manufacturer | Device | 510(k) Number |
|---|---|---|
| Nobel Biocare | Procera Abutment Branemark, Models10-4001, 10-40 | K042658 |
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™ Abutment in Zirconia is made of the biocompatible material, yttriastabilized tetragonal zirconia polycrystals (Y-TZP) (Meets ISO standards 6872 & 13356) and the abutment screw is made from Titanium grade Ti-6A1-4V ELI (Meets ASTM Standard F-136).
Intended Use of the Device న్.
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™ Abutment in Zirconia is substantially equivalent in intended use, material, design and performance to the Nobel Biocare Procera Abutment Branemark cleared under K042658.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Atlantis Components Incorporated C/O Ms. Betsy A. Brown Manager, Regulatory & Quality B.A. Brown & Associates 8944 Tamaroa Terrace Skokie, Illinois 60076
Re: K052070
Trade/Device Name: Atlantis™ Abutment in Zirconia Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abument Regulatory Class: II Product Code: NHA Dated: July 29, 2005 Received: August 1, 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.
OCT 1 4 2005
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Page 2 - Ms. Brown
Please be advised that FDA's issuance of a substantial equivalence determination does not Fleast be advised that I Da determination that your device complies with other requirements nicall that 1 Dr may Federal statutes and regulations administered by other Federal agencies. of the Act of ally I outral black s requirements, including, but not limited to: registration 1 ou intilest comply was a 807); labeling (21 CFR Part 801); good manufacturing practice alle listing (21 es read on the quality systems (QS) regulation (21 CFR Part 820); and if requirements as betrenic 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) This letter will anow you to began 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), rt you decire type at 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,
Sutie y. Michael Davis.
Chiú 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 - 000227
Indications for Use
510(k) Number (if Known) 1052070
Device Name: Atlantis IM Abutment in Zirconia
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 support a prosinent device in a particity of costhesis, in the mandible or maxilla. The for use to support single and manapie the abutment. The abutment screw is intended to prosure the abutment to the endosseous implant.
This device is compatible with the following manufacturers' implant systems having an external hex with flat-to-flat dimensions of 2.7mm or greater: Nobel Biocare, 3i, Lifecore, Sterngold ImplaMed, Innova, and BioHorizons.
Steringold inforded, may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.
Prescription Use
(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)
Suser Keare
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital, Infection Control, Dental Device
510(k) Number:
§ 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.)