(208 days)
Not Found
No
The summary describes a physical dental abutment and its compatibility with various implant systems. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is an accessory to an endosseous implant designed to support prosthetic reconstructions in dental patients. It does not exert any direct therapeutic action itself.
No
The device is an accessory to an endosseous implant designed to support a prosthetic reconstruction, not to perform a diagnostic function.
No
The device description clearly states that the device is a physical abutment made of titanium, which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as an accessory to a dental implant to support a prosthetic reconstruction in a patient. This is a direct medical intervention within the body, not a test performed on samples taken from the body.
- Device Description: The description details the physical components and how they are used in a dental procedure. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's health status
- Use in a laboratory setting
The device is a medical device used in a surgical/dental procedure, not an in vitro diagnostic test.
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 reconstruction 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 3i MicroMini Implant is compatible with the 3i: Osseotite NT® Certain and Parallel Walled Implants both with 3.25mm diameter; Nobel Biocare: NT & Ceram and Farmer Caraner S.3mm, HL Immediate Impression 3.25mm, Cylindrical HL Series 3.25mm; BioHorizons: Maestro™ 3.5mm; Lifecore: Self-tapping 3.75mm, Threaded 3.3mm, Cylinder 3.4mm, Titanium 3.3mm; Sterngold: Implamed Hex Screw 3.3mm, 3.75mm, 4.0mm and 5.0mm, Hex Cylinder 3.3mm; Innova: Endopore® External 3.5mm and Entegra™ External 3.25mm.
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™ Abutments for 31 MicroMini Implant and abutment screws are made I ne Atlantis - 110 am 2012 (Meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The placed over the mipatible with 3i Ossectite NT® Certain™ Implant 3.25mm and Parallel abulled Implant 3.25mm; Nobel Biocare Mk III 3.3mm, Threaded HL Series 3.3mm, HL Wared Impression 3.25mm, Cylindrical HL Series 3.25mm; BioHorizons Maestro™ 1.5mm; Lifecore Self-tapping 3.75mm, Threaded 3.3mm, Cylinder 3.4mm, Titanium 3.3mm; Sterngold Implamed Hex Screw 3.3mm, 3.75mm, 4.0mm and 5.0mm; Innova Endopore® external 3.5mm and Entegra™ External 3.25mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible or maxilla, anterior region of the mouth, posterior region
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.)
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1 of 2
Pre-market Notification Page - 00009 - - - - - - - - - - - - - - - -
VII. SECTION 10 - 510(K) SUMMARY
FEB 1 4 2007
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 617-661-9799 Telephone Number: 617-661-9063 Fax Number: Franklin Uyleman Contact Person: Manager of Quality and Regulatory Affairs
2. Name of Device
| Trade Name: | Atlantis™ Abutment for 3i MicroMini
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 |
|-----------------------------|-----------------------------------------|------------------|
| Atlantis Components
Inc. | Atlantis Abutment and Abutment
Screw | K981858 |
| 3i Implant Innovations | Osseotite NT Dental Implants | K014235 |
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.
1
Pre-market Page - 00010 --------------------
Description of the Device (continued) 4.
The Atlantis™ Abutments for 31 MicroMini Implant and abutment screws are made I ne Atlantis - 110 am 2012 (Meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The placed over the mipatible with 3i Ossectite NT® Certain™ Implant 3.25mm and Parallel abulled Implant 3.25mm; Nobel Biocare Mk III 3.3mm, Threaded HL Series 3.3mm, HL Wared Impression 3.25mm, Cylindrical HL Series 3.25mm; BioHorizons Maestro™ 1.5mm; Lifecore Self-tapping 3.75mm, Threaded 3.3mm, Cylinder 3.4mm, Titanium 3.3mm; Sterngold Implamed Hex Screw 3.3mm, 3.75mm, 4.0mm and 5.0mm; Innova Endopore® external 3.5mm and Entegra™ External 3.25mm.
Intended Use of the Device 5.
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.
Basis for Substantial Equivalence . ୧.
The Atlantis™ Abutments for 3i MicroMini Implants are substantially equivalent in intended use, material, design and performance to the Atlantis Abutments cleared under K981858 and the 3i Osseotite NT Dental Implant System K014235.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body, symbolizing service, strength, and skill. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 4 2007
Atlantis Components, Incorporated C/O Ms. Betsy A. Brown Consultant B.A. Brown & Associates 8944 Tamaroa Terrace Skokie, Illinois 60076
Re: K062069
Trade/Device Name: Atlantis™ Abutment for 3i MicroMini Implant Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: February 6, 2007 Received: February 12, 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.
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 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Syitte y. Michai Oms
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)
Device Name: Atlantis ™ Abutment for 31 MicroMini Implant
Indication for Use:
The Atlantis Abutment is intended for use as an accessory to an endosseous implant to I he i thanks ribution in a partially or completely edentulous patient. It is intended Support a probable in the multiple tooth prosthesis, in the mandible or maxilla. The 10. ase to support bangle and ined to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
The Atlantis Abutment for 3i MicroMini Implant is compatible with the 3i: Osseotite NT® Certain and Parallel Walled Implants both with 3.25mm diameter; Nobel Biocare: NT & Ceram and Farmer Caraner S.3mm, HL Immediate Impression 3.25mm, Cylindrical HL Series 3.25mm; BioHorizons: Maestro™ 3.5mm; Lifecore: Self-tapping 3.75mm, Threaded 3.3mm, Cylinder 3.4mm, Titanium 3.3mm; Sterngold: Implamed Hex Screw 3.3mm, 3.75mm, 4.0mm and 5.0mm, Hex Cylinder 3.3mm; Innova: Endopore® External 3.5mm and Entegra™ External 3.25mm.
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)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CQRH, Office of Device Evaluation (ODE) Sugar Conser
AND/OR
(Division Sign-Om Division of Anasiliestology, General Hospital. Infection Control, Disntal Devices
5100k) Normoer