(135 days)
Not Found
No
The summary describes a dental abutment and its materials, intended use, and compatibility with existing implant systems. There is no mention of AI, ML, or any computational processing that would suggest the use of such technologies.
No
The device is an accessory to an endosseous implant to support a prosthetic device, which is not a therapeutic function. It is a structural component for dental restoration.
No
Explanation: The device is an abutment for dental implants, used to support prosthetic devices. It does not perform any diagnostic functions like detecting, characterizing, or monitoring diseases or conditions.
No
The device description clearly states the device is an abutment made of physical materials (zirconia and titanium) and is a physical component placed into a dental implant.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Atlantis Abutment is a physical device (an abutment and screw) that is surgically placed into a dental implant within the patient's mouth. It is used to support a prosthetic device.
- Intended Use: The intended use is to support a prosthetic device in a patient, not to perform a diagnostic test on a sample.
The description clearly indicates a medical device used in vivo (within the body) for structural support, not a diagnostic test performed in vitro (outside 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.
This device is compatible with the following manufacturers' implant systems: Nobel Biocare, Zimmer Dental, 3i, Lifecore, Sterngold, Innova and BioHorizons.
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.
Also, 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.
Product codes
NHA
Device Description
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 in Zirconia for Nobel Replace is made of biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards 6972 & 13356). The abutment screw is made from titanium grade Ti-6A1-V ELI and 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 Nobel Replace® Select Straight, Replace Select Straight One Stage, Replace Select Tapered and Replace Select Tapered One Stage for the 4.3 mm (RP), 5.0 mm (WP) and 6.0 mm (WP) Implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible or maxilla
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
DEC 2 0 2006
Pre-market Notification Page - 00009 - - - - - - - - - - - - - - - -
8062277
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 for Nobel Biocare
Replace |
|----------------------|------------------------------------------------------------------------|
| 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 Components
Inc. | Atlantis Abutment and Abutment
Screw | K981858 |
| Nobel Biocare | Replace TiUnite | K023113 |
| Atlantis Components
Inc. | Atlantis Abutment in Zirconia | K052070 |
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.
1
Pre-market Page - 00010 - - - - - - - - - - - - - -
4. Description of the Device (continued)
The Atlantis™ Abutments in Zirconia for Nobel Replace is made of biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards 6972 & 13356). The abutment screw is made from titanium grade Ti-6A1-V ELI and 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 Nobel Replace® Select Straight, Replace Select Straight One Stage, Replace Select Tapered and Replace Select Tapered One Stage for the 4.3 mm (RP), 5.0 mm (WP) and 6.0 mm (WP) Implants.
5. 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.
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.
6. Basis for Substantial Equivalence
The Atlantis™ Abutments in Zirconia for Nobel Replace are substantially equivalent in intended use, material, design and performance to the Atlantis Abutments cleared under K981858, Nobel Biocare Replace TiUnite Implants cleared under K023112 and Atlantis Abutment in Zirconia cleared under K052070.
2
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 2006
Mr. Franklin Üyleman Manager, Regulatory & Quality Atlantis Components, Incorporated 25 First Street Cambridge, Massachusetts 02141
Re: K062277
Trade/Device Name: Atlantis™ Abutment in Zirconia for Nobel Replace Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: November 28, 2006 Received: December 1, 2006
Dear Mr. Uyleman:
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.
3
Page 2 -Mr. Uyleman
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 (OS) 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,
Clus
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 - 000227
Indications for Use
510(k) Number (if Known) k 062277
Device Name: Atlantis ™ Abutment in Zirconia for Nobel Replace
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.
This device is compatible with the following manufacturers' implant systems: Nobel Biocare, Zimmer Dental, 3i, Lifecore, Sterngold, Innova and BioHorizons.
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.
Also, 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.
Susan Dunne
ivision Sign-Off sion of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K062277
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 Hosp
Control, Cental Devices
K(6)-1-76