(208 days)
The Atlantis Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic reconstruction 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 Atlantis Abutment for 3i MicroMini Implant is compatible with the 3i: Osseotite NT® Certain and Parallel Walled Implants both with 3.25mm diameter; Nobel Biocare: Mk III 3.3mm, Threaded HL Series 3.3mm, HL Immediate Impression 3.25mm, Cylindrical HL Series 3.25mm; BioHorizons: Maestro™ 3.5mm; Lifecore: Self-tapping 3.75mm, Threaded 3.3mm, Cylinder 3.4mm, Titanium 3.3mm; Sterngold: Implamed Hex Screw 3.3mm, 3.75mm, 4.0mm and 5.0mm, Hex Cylinder 3.3mm; Innova: Endopore® External 3.5mm and Entegra™ External 3.25mm.
Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the 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 31 MicroMini Implant and abutment screws are made I ne Atlantis - 110 am 2012 (Meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The placed over the mipatible with 3i Ossectite NT® Certain™ Implant 3.25mm and Parallel abulled Implant 3.25mm; Nobel Biocare Mk III 3.3mm, Threaded HL Series 3.3mm, HL Wared Impression 3.25mm, Cylindrical HL Series 3.25mm; BioHorizons Maestro™ 1.5mm; Lifecore Self-tapping 3.75mm, Threaded 3.3mm, Cylinder 3.4mm, Titanium 3.3mm; Sterngold Implamed Hex Screw 3.3mm, 3.75mm, 4.0mm and 5.0mm; Innova Endopore® external 3.5mm and Entegra™ External 3.25mm.
Here's a breakdown of the acceptance criteria and study information for the Atlantis™ Abutment for 3i MicroMini Implant, based on the provided text, recognizing that this is a 510(k) summary and not a full study report.
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel clinical trial for device-specific performance criteria. Therefore, explicit "acceptance criteria" and "device performance" in the typical sense of a clinical study with statistical endpoints are not present. Instead, the "acceptance criteria" are implied by the claim of substantial equivalence in "intended use, material, design and performance" to the predicate devices. The "reported device performance" is essentially the statement that it meets these equivalence criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence Claim) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: To serve as an accessory for an endosseous implant to support a prosthetic reconstruction in partially or completely edentulous patients, supporting single and multiple tooth prosthesis (mandible/maxilla), with cement-retained prostheses, and securing the abutment to the implant. | The Atlantis™ Abutment for 3i MicroMini Implant is substantially equivalent in intended use to the Atlantis Abutments (K981858) and the 3i Osseotite NT Dental Implant System (K014235). The intended use is clearly defined in the "Indications for Use" section and matches the predicate's function. |
| Material Equivalence: Made from Ti 6Al 4V ELI (Meets ASTM Standard F-136). | The Atlantis™ Abutments for 3i MicroMini Implant and abutment screws are made from Ti 6Al 4V ELI (Meets ASTM Standard F-136), indicating material equivalence to existing market devices. |
| Design Equivalence: Compatible with specific implant systems (listed in the document). | The device is substantially equivalent in design to the predicate. Compatibility with a wide range of listed implant systems (3i, Nobel Biocare, BioHorizons, Lifecore, Sterngold, Innova) is stated, implying a design that fits these systems as intended. |
| Performance Equivalence: Functional performance (e.g., strength, durability, secure fit) akin to the predicate devices with established safety and efficacy. | The device is substantially equivalent in performance to the predicate. While specific performance metrics (e.g., fracture strength values, fatigue testing results) are not provided in this summary, the claim of substantial equivalence implies that such testing (often mechanical) was conducted to demonstrate comparable performance to the predicate and deemed acceptable by the FDA. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not specify a separate "test set" sample size in the context of a clinical performance study. This is a 510(k) submission, primarily relying on comparison to predicate devices and (implied) bench testing rather than a new clinical trial.
- Data Provenance: Not applicable in the context of a clinical test set. The data provenance supporting the substantial equivalence would come from the manufacturer's internal testing (mechanical, material characterization) and comparison to the known characteristics of the predicate devices. There is no mention of country of origin for clinical data as no clinical study demonstrating new performance data is described for this specific device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications
- Number of Experts: Not applicable. There is no mention of experts establishing ground truth for a clinical test set in this 510(k) summary. The "ground truth" for substantial equivalence is based on engineering principles, material science, and regulatory comparison.
4. Adjudication Method for the Test Set
- Adjudication method is not applicable as there is no described clinical test set involving human assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
- No, an MRMC comparative effectiveness study was not done. This document pertains to a dental implant abutment, where performance is typically assessed through mechanical testing and equivalence to existing devices, not through human reader interpretation of images or data that would necessitate an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a passive mechanical component (an abutment for a dental implant), not an algorithm or AI system.
7. The type of ground truth used
- The "ground truth" for this 510(k) submission is the established performance and safety profiles of the predicate devices (Atlantis Abutments K981858 and 3i Osseotite NT Dental Implant System K014235). The applicant aims to demonstrate that the new device's material, design, intended use, and performance are equivalent to these legally marketed devices. This would typically be supported by:
- Mechanical Testing Data: (Implied) to show comparable strength, fatigue resistance, and fit.
- Material Characterization: (Stated: Ti 6Al 4V ELI, ASTM F-136 compliance).
- Design Specifications: Showing compatibility with target implant systems.
8. The Sample Size for the Training Set
- Not applicable. This submission describes a physical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set for an AI/ML algorithm, no ground truth establishment for such a set is relevant.
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Pre-market Notification Page - 00009 - - - - - - - - - - - - - - - -
VII. SECTION 10 - 510(K) SUMMARY
FEB 1 4 2007
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: Franklin Uyleman Contact Person: Manager of Quality and Regulatory Affairs
2. Name of Device
| Trade Name: | Atlantis™ Abutment for 3i MicroMiniImplant |
|---|---|
| Common Name: | Endosseous dental implant abutment |
| Classification Name: | Endosseous dental implant abutment21 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 |
| 3i Implant Innovations | Osseotite NT Dental Implants | K014235 |
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 - 00010 --------------------
Description of the Device (continued) 4.
The Atlantis™ Abutments for 31 MicroMini Implant and abutment screws are made I ne Atlantis - 110 am 2012 (Meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The placed over the mipatible with 3i Ossectite NT® Certain™ Implant 3.25mm and Parallel abulled Implant 3.25mm; Nobel Biocare Mk III 3.3mm, Threaded HL Series 3.3mm, HL Wared Impression 3.25mm, Cylindrical HL Series 3.25mm; BioHorizons Maestro™ 1.5mm; Lifecore Self-tapping 3.75mm, Threaded 3.3mm, Cylinder 3.4mm, Titanium 3.3mm; Sterngold Implamed Hex Screw 3.3mm, 3.75mm, 4.0mm and 5.0mm; Innova Endopore® external 3.5mm and Entegra™ External 3.25mm.
Intended Use of the Device 5.
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. Please note: Highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to the limited strength of the implant fixture.
Basis for Substantial Equivalence . ୧.
The Atlantis™ Abutments for 3i MicroMini Implants are substantially equivalent in intended use, material, design and performance to the Atlantis Abutments cleared under K981858 and the 3i Osseotite NT Dental Implant System K014235.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body, symbolizing service, strength, and skill. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 4 2007
Atlantis Components, Incorporated C/O Ms. Betsy A. Brown Consultant B.A. Brown & Associates 8944 Tamaroa Terrace Skokie, Illinois 60076
Re: K062069
Trade/Device Name: Atlantis™ Abutment for 3i MicroMini Implant Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: February 6, 2007 Received: February 12, 2007
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,
Syitte y. Michai Oms
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 - 000227
Indications for Use
510(k) Number (if Known)
Device Name: Atlantis ™ Abutment for 31 MicroMini Implant
Indication for Use:
The Atlantis Abutment is intended for use as an accessory to an endosseous implant to I he i thanks ribution in a partially or completely edentulous patient. It is intended Support a probable in the multiple tooth prosthesis, in the mandible or maxilla. The 10. ase to support bangle and ined to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
The Atlantis Abutment for 3i MicroMini Implant is compatible with the 3i: Osseotite NT® Certain and Parallel Walled Implants both with 3.25mm diameter; Nobel Biocare: NT & Ceram and Farmer Caraner S.3mm, HL Immediate Impression 3.25mm, Cylindrical HL Series 3.25mm; BioHorizons: Maestro™ 3.5mm; Lifecore: Self-tapping 3.75mm, Threaded 3.3mm, Cylinder 3.4mm, Titanium 3.3mm; Sterngold: Implamed Hex Screw 3.3mm, 3.75mm, 4.0mm and 5.0mm, Hex Cylinder 3.3mm; Innova: Endopore® External 3.5mm and Entegra™ External 3.25mm.
Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.
Prescription Use (Part 21 CFR 801 SubpartD)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CQRH, Office of Device Evaluation (ODE) Sugar Conser
AND/OR
(Division Sign-Om Division of Anasiliestology, General Hospital. Infection Control, Disntal Devices
5100k) Normoer
§ 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.)