(87 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 Atlantis Abutment for Astra Implant is compatible with Astra's OsseoSpeed™ 3.5(S) mm, 4.0(S) mm Internal Hex Implants.
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 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 3.5 S mm, 4.0 S mm OsseoSpeed™ Implants.
The provided text is a 510(k) summary for a dental device, the Atlantis™ Abutment for Astra Implant. It primarily focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a performance study with detailed acceptance criteria and a comprehensive study report.
Therefore, many of the requested sections regarding performance criteria, study design, and ground truth establishment cannot be found in this document. The purpose of a 510(k) is often to show that a new device is as safe and effective as a legally marketed one, which can be done through comparison of materials, intended use, and design, without necessarily requiring a new, extensive clinical performance study if the differences are minor.
Here's an analysis of the information that is available in the provided text, and where the requested information is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a study. The "basis for substantial equivalence" is the primary "acceptance criterion" in this context.
- Reported Device Performance: No specific performance metrics (e.g., success rates, longevity, strength) are reported for the device in a formal study within this document. The document states that the device is "substantially equivalent in intended use, material, design and performance" to predicate devices.
| Acceptance Criteria (Inferred from 510(k) purpose) | Reported Device Performance (from K070833) |
|---|---|
| Substantial equivalence in intended use | Claimed substantial equivalence |
| Substantial equivalence in material | Claimed substantial equivalence |
| Substantial equivalence in design | Claimed substantial equivalence |
| Substantial equivalence in performance | Claimed substantial equivalence |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document does not describe a performance study with a test set. It's a regulatory submission focused on substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. No test set or ground truth establishment by experts is described in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This document does not describe a performance study requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This device is a dental abutment, not an AI-powered diagnostic tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical dental component, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No explicit performance study requiring ground truth is described. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
- Not Applicable. This document does not describe the development of an algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. No training set or ground truth establishment for a training set is described.
Summary from the Document:
The K070833 submission for the Atlantis™ Abutment for Astra Implant establishes its substantial equivalence to existing, legally marketed predicate devices rather than providing a new, independent performance study against specific acceptance criteria. The claim of equivalence is based on the device's intended use, material (Titanium grade Ti-6Al-4V ELI), design, and performance being similar to:
- Atlantis Abutment for 3i MicroMini (K062069)
- Atlantis Abutment for Astra Fixture (K053384)
- Astra Tech MicroThread™ OsseoSpeed™ (K024111)
- Astra Tech Implants-Dental System Fixture MicroMacro (No 510(k) number provided in table, but referenced)
This type of 510(k) filing relies on the FDA's prior determination of safety and effectiveness for the predicate devices.
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Pre-market Notification Page - 000009 - - - - - - - - - - - - - - -
JUN 2 2 2007
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 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 |
3. Legally Marketed Device to which Equivalence is claimed (Predicate Device)
| Manufacturer | Device | 510(k)Number |
|---|---|---|
| Atlantis ComponentsInc. | -Atlantis Abutment for 3i MicroMini-Astra Fixture | K062069K053384 |
| Astra Tech Inc | MicroThread™OsseoSpeed™ | K024111 |
| Astra Tech inc. | -Astra Tech Implants-Dental SystemFixture MicroMacro |
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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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 3.5 S mm, 4.0 S mm OsseoSpeed™ Implants.
న. 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 for 31 MicroMini cleared under K062069 and for the Astra Tech Implants cleared under K053384 and K024111.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Atlantis Components, Incorporated C/O Ms. Betsy A. Brown Consultant B.A. Brown & Associates 8944 Tamaroa Terrace Skokie, Illinois 60076
Rc: K070833
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: March 23, 2007 Received: March 27, 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.
JUN 2 2 2007
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chris Liu, 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 - 000227
Indications for Use
510(k) Number (if Known)
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.
The Atlantis Abutment for Astra Implant is compatible with Astra's OsseoSpeed™ 3.5(S) mm, 4.0(S) mm Internal Hex Implants.
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) 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)
Robert S. Betz DDS for Dr. Anna R.
esthesiology, General Hospital control inosthesiology, Gene
C(k) Number: K070833
§ 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.)