(16 days)
Not Found
No
The device description and intended use are purely mechanical, and there are no mentions of AI, ML, or related concepts.
No.
The device, Elliptic Matrix, is used to provide support and retention for an overdenture and does not appear to treat or mitigate a disease or condition.
No
The device, Elliptic Matrix, is described as providing support and retention for an overdenture and attaches to an abutment. Its function is purely mechanical (functioning like a spring, titanium housing for support), and there is no mention of it being used to diagnose a medical condition or disease.
No
The device description clearly states it is a physical component ("titanium housing") that attaches to an abutment and functions mechanically ("functioning like a spring"). This indicates a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide support and retention for an overdenture, which is a mechanical function within the body.
- Device Description: The description details a mechanical device that attaches to an abutment and functions like a spring.
- 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 specifically designed for testing biological samples outside of the body. This device is clearly intended for use within the oral cavity to support a denture.
N/A
Intended Use / Indications for Use
The Elliptic Matrix is attached onto the Straumann Retentive Anchor abutment to provide support and retention for an overdenture.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Elliptic Matrix attaches to the retentive anchor by functioning like a spring when the four lamellae are activated. The titanium housing gives the matrix more support and retention for the denture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Gold Matrix (K894844)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
MAR 1 8 2004
ATTACHMENT 6 - 510(k) Summary
Applicant's Name and Address 1.
Straumann USA (on behalf of Institut Straumann AG) Reservoir Place 1601 Trapelo Road Waltham, MA 02451 Telephone Number: 781-890-0001 781-890-0791 Fax Number: Contact Person: John King Regulatory Affairs
2. Name of the Device
| Trade Name: | Elliptic Matrix |
|---|---|
| Common Name: | Endosseous dental implant |
| Classification Name: | Endosseous dental implant |
| 21 CFR 872.3640 |
Legally Marketed Devices to which Equivalence is Claimed (Predicate 3. Devices)
Gold Matrix (K894844)
4. Description of the Device
The Elliptic Matrix attaches to the retentive anchor by functioning like a spring when the four lamellae are activated. The titanium housing gives the matrix more support and retention for the denture.
5. Intended Use of the Device
The Elliptic Matrix is attached onto the retentive anchor abulment to provide support and retention for denture.
റ. Basis for Substantial Equivalence
The subject device is substantially equivalent to previously cleared Gold Matrix. The intended use of the subject Elliptic Matrix is identical to the predicate Gold Matrix.
The subject device has an almost identical design as the predicate device. The labeling and instructions for use for both devices are similar.
510(k) Elliptic Matrix March 1, 2004 Page 16 of 20
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that suggest wings and a body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 8 2004
Institut Straumann AG C/O Mr. John King Regulatory Affairs Straumann USA Reservoir Place 1601 Trapelo Road Waltham, Massachusetts 02451
Re: K040539
Trade/Device Name: Elliptic Matrix Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: III Product Code: NHA Dated: March 1, 2004 Received: March 2, 2004
Dear Mr. King:
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.
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Page 2 -Mr. King
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 moan that I DT may must statutes and regulations administered by other Federal agencies. or the For of any I ouchar the Act's requirements, including, but not limited to: registration r od inust comply with a wart 807); labeling (21 CFR Part 801); good manufacturing practice and libang (2) es a set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirence as lectronic 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) This letter will and in yourse Finding of substantial equivalence of your device to a premaired predicate in - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), rryou desire specific at 100 201 pliance at (301) 594-4613. 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/cdrl/dsma/dsmamain.html
Sincerely yours,
Susan Runner
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
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Page 1 of_1
510(k) Number (if known):
Elliptic Matrix Device Name:
Indications For Use:
The Elliptic Matrix is attached onto the Straumann Retentive Anchor abutment to provide support and retention for an overdenture.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
Kein Whaley son V.S.R
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K040539
510(k) Elliptic Matrix March 1, 2004 Page 19 of 20