(116 days)
No
The document describes a physical dental abutment and its intended use, materials, and compatibility. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
No.
A therapeutic device is one that treats a disease or condition. This device, an abutment, supports a prosthetic device to replace missing teeth, which is a restorative function, not a therapeutic one.
No
The device, an Atlantis Abutment, is described as supporting a prosthetic device on an endosseous implant. Its function is purely mechanical support and does not involve diagnosing a condition or disease.
No
The device description clearly states the device is a physical abutment made of Titanium, which is a hardware component.
Based on the provided information, 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 Function: The Atlantis Abutment is a physical device intended to be implanted into a patient's jawbone to support a dental prosthesis. It is a medical device used in vivo (within the body), not in vitro (outside the body).
- Intended Use: The intended use clearly describes its function in supporting a prosthetic device in a patient, not in analyzing biological samples.
Therefore, the Atlantis Abutment falls under the category of a medical device, specifically a dental implant component, and not an IVD.
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 maxillary lateral incisors and mandibular lateral and central incisors. 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 Astra Tech OsseoSpeed 3.0 mm Implant.
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™ Abutments for Astra Tech OsseoSpeed 3.0 Implant System 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 3.0 mm OsseoSpeed™ Implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary lateral incisors and mandibular lateral and central incisors.
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 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
OCT 0 7 2008
Pre-market Notification Page - 000009
006
K081666
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
Astra Tech 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 Tech OsseoSpeed
3.0 Implant System |
|--|----------------------|------------------------------------------------------------------------|
| | 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 |
|------------------------------------------------------------|--------------------------------------|------------------|
| Astra Tech Inc.,
(formerly Atlantis
Components Inc.) | -Atlantis Abutment for Astra Implant | K070833 |
| Astra Tech AB | -OsseoSpeed™ Narrow | K080396 |
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
K08/666
2072
Pre-marke ?age - 000010 - - - - - - - - - - - - - -
4. Description of the Device (continued)
The Atlantis™ Abutments for Astra Tech OsseoSpeed 3.0 Implant System 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 3.0 mm OsseoSpeed™ Implants.
న్. 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 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 maxillary lateral incisors and mandibular lateral and central incisors. 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 OsseoSpeed 3.0 Implants are substantially equivalent in intended use, material, design and performance to the Atlantis Abutments tor Astra Implants cleared under K070833 and for the Astra Tech OsseoSpeed TM Narrow Implants cleared under K080396.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's name arranged in a circular fashion around a stylized symbol. The symbol is a depiction of an abstract eagle, with its wings forming three distinct, curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 0 7 2008
Astra Tech, Incorporated C/O Ms. Betsy A. Brown Consultant B.A. Brown & Associates 8994 Tamaroa Terrace Skokie, Illinois 60076
Re: K081666
Trade/Device Name: Atlantis™ Abutment for Astra Tech OsseoSpeed 3.0 Implant System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: September 24, 2008 Received: September 26, 2008
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.
3
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 ogencies. You must comply with all the Act's requirements, including, but not limited to: registerior 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 parmits 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 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 regading postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.
THAmuels Lend, ms for//
Chiu S. Lin, Ph. D Division 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)
Device Name: Atlantis ™ Abutment for Astra Tech OsseoSpeed 3.0 Implant System
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 maxillary lateral incisors and mandibular lateral and central incisors. 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 Astra Tech OsseoSpeed 3.0 mm Implant.
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 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)
Susan Runrel
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: