(43 days)
Not Found
No
The document describes a physical dental abutment and its materials, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device is an abutment for a dental implant, which supports a prosthetic device. It does not provide any therapeutic benefit or treatment of disease.
No
The device is an abutment that supports a prosthetic device on a dental implant. Its function is structural, not diagnostic.
No
The device description clearly states the device is an abutment made of titanium and zirconia, which are physical materials, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for supporting a prosthetic device in a patient, placed directly into a dental implant. This is a therapeutic and structural function within the body.
- Device Description: The description details the materials and placement of the abutment within the dental implant, again focusing on its structural role in supporting a prosthesis.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic purposes. IVDs are typically used for testing blood, urine, tissue, etc., to detect diseases or conditions.
This device is a dental implant abutment, which is a medical device used in dentistry for restorative purposes.
N/A
Intended Use / Indications for Use
The Atlantis Abutment is intended for use with 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 or screw 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: The titanium and zirconia abutments are compatible with the Nobel Biocare's NobelActive 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.
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™ Abutment for Nobel Biocare Active Implant and abutment screw are made from Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) for the 3.5mm, 4.3mm and 5.0mm sizes. In addition, the Atlantis™ Abutment for Nobel Biocare Active Implant for the 3.5mm, 4.3mm and 5.0mm sizes, also are made of the biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) (meets ISO Standards 6072 & 13356). Zirconia may have a variation in shade. The titanium and the zirconium abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.
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
dental professional
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
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 - - - - - - - - - - - - - - -
DEC 22 2009
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.
Astra Tech Inc. 590 Lincoln Street Waltham, Massachusetts 02451 781-810-6462 Telephone Number: 781-810-6719 Fax Number: Contact Person: Franklin Uyleman Manager of Quality and Regulatory Affairs
Name of Device 2.
| Trade Name: | Atlantis™ Abutment for Nobel Active Implant |
|---|---|
| Common Name: | Endosseous dental implant abutment |
| Classification Name: | Endosseous dental implant abutment |
| 21 CFR 872.3630 Product code NHA |
Legally Marketed Device to which Equivalence is claimed (Predicate Device) 3.
| Manufacturer | Device | 510(k)
Number |
|---------------|--------------------------------------------|------------------|
| Nobel Biocare | Nobelactive Internal Connection
Implant | K071370 |
| Nobel Biocare | Nobelactive Zirconia Abutment | K072129 |
1
Pre-market Notification Page - 000010 - - - - - - - - - - - - - - - - - -
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. The Atlantis™ Abutment for Nobel Biocare Active Implant and abutment screw are made from Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) for the 3.5mm, 4.3mm and 5.0mm sizes. In addition, the Atlantis™ Abutment for Nobel Biocare Active Implant for the 3.5mm, 4.3mm and 5.0mm sizes, also are made of the biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) (meets ISO Standards 6072 & 13356). Zirconia may have a variation in shade. The titanium and the zirconium abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.
న. Intended Use of the Device
The Atlantis Abutment is intended for use with 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:
The titanium and zirconia abutments are compatible with the Nobel Biocare's NobelActive Implants: NP 3.3mm, RP 4.3mm and 5.0 mm sizes
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.
2
Pre-market Notification Page - 000010a - - - - - - - - - - - - - -
6. Basis for Substantial Equivalence
i
The Atlantis™ Abutments for Nobel Biocare Active Implants are substantially equivalent in intended use, material, design and performance to the Nobel Biocare Nobelactive Internal Connection Implant System cleared under K071370 and the Nobel Biocare Nobelactive Zirconia Abutment cleared under K072129.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is left-aligned. The words are stacked on top of each other, with 'Public' on the top line, 'Health' on the second line, and 'Service' on the third line. The text appears to be part of a larger document or sign.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Astra Tech Incorporated C/o Ms. Betsy A. Brown B.A. Brown & Associates 8944. Tamaroa Terrace Skokie, Illinois 60076
EC 2 2 2 2009
Re: K093483
Trade/Device Name: Atlantis™ Abutment for Nobel Biocare Active Implant Regulation Number: 21 CFR 872.3630 Regulatory Class: II Product Code: NHA Dated: July 27, 2009 Received: November 9, 2009
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 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.
4
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Pre-market Notification Page - 000227
Indications for Use
510(k) Number (if Known)
Device Name: Atlantis TM Abutment for Nobel Biocare Active Implant
Indication for Use:
The Atlantis Abutment is intended for use with 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 or screw 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:
The titanium and zirconia abutments are compatible with the Nobel Biocare's NobelActive 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.
RSBetz DMS for Dr. K.P. Mulry (Acting)
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K093483
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)