(56 days)
No
The 510(k) summary describes a standard dental abutment and screw made of titanium. There is no mention of AI, ML, image processing, or any software-driven functionality that would suggest the use of these technologies. The description focuses solely on the material, compatibility, and mechanical function of the device.
No
The device is described as an accessory to an endosseous implant to support a prosthetic device, which is restorative in nature, not therapeutic.
No
The device is described as an accessory to an endosseous implant to support a prosthetic device, which is a therapeutic function, not a diagnostic one. There is no mention of it being used to detect, monitor, or identify a medical condition.
No
The device description clearly states the device is made from Titanium and is a physical abutment and screw, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Atlantis Abutment is an accessory to an endosseous implant to support a prosthetic device in a patient. This describes a device used in vivo (within the body) for structural support.
- Device Description: The description details the material and how the abutment is placed and secured to an implant within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from the body, not devices implanted into the body.
N/A
Intended Use / Indications 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.
Product codes
NHA
Device Description
The Atlantis™ Abutments for Straumann Interface 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 Straumann Standard Regular Neck (RN) implants with 3.3, 4.1, and 4.8mm diameters; Standard Plus Regular Neck (RN) with 3.3, 4.1, and 4.8mm diameters and the Tapered Effect Regular Neck (RN) with the 3.3 and 4.1mm diameters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mandible or maxilla (dental implant site)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.)
0
Pre-market Notification Page - 000009 MAR 7 - 2005
SECTION 10 - 510 (K) SUMMARY VII.
This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR Part 807.92.
Applicants Name and Address .
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 Customer Service
2. Name of Device
Atlantis ™ Abutment for Straumann Interface Trade Name: Endosseous dental implant abutment Common Name: Endosseous dental implant abutment Classification Name: 21 CFR 872.3630 Product code NHA
Legally Marketed Device to which Equivalence is claimed (Predicate Device) 3.
| Manufacturer | Device | 510(k) Number |
|---|---|---|
| Atlantis Components Inc. | Atlantis Abutment and | |
| Abutment Screw | K981858 |
- 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.
1
Pre-market Notification Page -= = = = = = = = = = = = = = = = =
Description of the Device (continued) 4,
The Atlantis™ Abutments for Straumann Interface 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 Straumann Standard Regular Neck (RN) implants with 3.3, 4.1, and 4.8mm diameters; Standard Plus Regular Neck (RN) with 3.3, 4.1, and 4.8mm diameters and the Tapered Effect Regular Neck (RN) with the 3.3 and 4.1mm diameters.
Intended Use of the Device ಳು
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 રું.
The Atlantis™ Abutments for Straumann Interface are substantially equivalent in intended use, material, design and performance to the Atlantis Abutments cleared under K981858.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure. The symbol is composed of three curved lines that converge to form the shape of a bird's head and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 7 - 2005
Atlantis Components, Incorporated C/O Ms. Betsy Brown Consultant B.A. Brown & Associates 8944 Tamaroa Terrace Skokie, Illinois 60076
Re: K050052
K050052
Trade/Device Name: Atlantis™ Abutment for Straumann Interface Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: NHA Dated: January 6, 2005 Received: January 10, 2005
Dear Ms. Brown:
We have reviewed your Section 510(k) premarket notification of intent to market the device the We have reviewed your Scenon 210(tr) promation is substantially equivalent (for the referenced above and have determined the active in analy in the Medical Devices marketed in
indications for use stated in the enclosure) to legally markets of the Medical Dev indications for tise stated in the cherosared to to regulared date of the Medical Device with the provision interstate commerce prior to way 20, 1770, the childed in accordance with the provisions of Amendments, or to devices that have been recurse approval of approval of a prematked the Federal Food, Drug, and Cosmetic Act (71ct) that she ice, subject to the general
approval application (PMA). You may, therefore, market the Aet include approval application (1 MA). 1 od may, macontrols provisions of the Act include controls provisions of the Act. "The genting of devices, good manufacturing practice, requirements for annual regionst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III II your device is classified (see above) into controls. Fxisting major regulations affecting (PMA), it may be subject to such additional controls: Title 21, Tarts 800 to 898. In
your device can be found in the Code of Federal Regulations, Title 21, the Federal your device can be found in the Code of Pederal Regioner of the Federal Register.
3
Page 2 - Ms. Brown
Please be advised that FDA's issuance of a substantial equivalence determination does not I least that FDA has made a determination that your device complies with other requirements Incall that I DA nas made a determand regulations administered by other Federal agencies. UI the Act of ally i oderal baker and equirements, including, but not limited to: registration 1 ou must comply with and 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 007), labelity systems (QS) regulation (21 CFR Part 820); and if requirements as sectionic 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) I mis letter will and in you be organization of substantial equivalence of your device to a promatics notification. - The Presults 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), r you desire specific advise 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 may obtain 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,
Ching-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
4
Pre-market Notification Page -000205
Indications for Use
1050052 510(k) Number (if Known)
Device Name: Atlantis ™ Abutment for Straumann Interface
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)
Anesthesiology, General Hospil. on Control, Dental Devices
Number: 1050052
693000