(272 days)
Not Found
No
The 510(k) summary describes standard dental implant abutments and related components, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices.
No
The device is described as an abutment used to support prosthetic restorations for dental implants, which is a supportive component rather than a device intended to treat or cure a disease or condition.
No
The device, Spectra-System Abutments, is described as providing support for prosthetic restorations in dental implants; its function is structural and restorative, not diagnostic.
No
The device description explicitly lists physical components such as "Non-Engaging Titanium Temporary Abutments," "Angled Screw-Receiving Abutments," and other abutment types, indicating it is a hardware device.
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 Description and Intended Use: The description clearly states that the Spectra-System Abutments are physical components designed to be used in support of dental implants within the patient's mouth (mandible or maxilla) to support prosthetic restorations. They are not used to analyze samples taken from the body.
The device is a medical device, specifically a dental prosthetic component, but it does not fit the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Spectra-System Abutments are designed to be used in support of a dental implant(s) to provide support for prosthetic restorations such as crowns, bridges, overdentures or custom prosthetic fabrications in a partially or completely edentulous patient. Spectra-System Abutments are intended for use in the mandible or maxilla. Prostheses can be screw or cement retained to the abutment.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
Spectra-System Abutments 2008 consist of a number abutment used in conjunction with dental implants for provisional, permanent or laboratory fabrication of a final dental prosthesis. The system includes Non-Engaging Titanium Temporary Abutments, Angled Screw-Receiving Abutments, Narrow ("N" Series) Abutments, Non-Engaging Plastic Abutments, Non-Engaging Gold Abutments and related components.
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): 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.
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
Image /page/0/Picture/1 description: The image is a logo for Implant Direct LLC. The logo features a large letter "D" with a screw design on the left side. To the right of the "D" is the text "Implant Direct LLC" in a bold, sans-serif font. Below the "D" is the website address "www.implantdirect.com".
JAN 1 4 2009
Spectra-System Abutments 2008 Traditional 510(K) Submission
510(K) Summary (21CFR 807.92(a))
Submitter's Information Company Name: Implant Direct LLC Address: 27030 Malibu Hills Rd., Calabasas Hills, CA USA 91301 Telephone Number: 818-444-3300 Fax Number: 818-444-3400 Registration Number: 3001617766 Contact Person: Tom Gottenbos Date Summary Prepared: March 13, 2008 Classification Name: Abutment, Implant, Dental, Endosseous Common/Usual Name: Endosseous Dental Implant Abutment
- Device Trade Name: Spectra-System Abutments 2008
- Predicate Device(s): Implant Direct Spectra-System Dental Implant System 3. (K061319), Sulzer Dental Screw-Vent Dental Implant System Custom Cast Abutments (K011028), Nobel Replace Tapered Groovy Custom Cast Abutments (K050258), Nobel Replace Tapered Groovy Multi Unit Abutments (K050258)
4. Device Description:
Spectra-System Abutments 2008 consist of a number abutment used in conjunction with dental implants for provisional, permanent or laboratory fabrication of a final dental prosthesis. The system includes Non-Engaging Titanium Temporary Abutments, Angled Screw-Receiving Abutments, Narrow ("N" Series) Abutments, Non-Engaging Plastic Abutments, Non-Engaging Gold Abutments and related components.
5. Intended Use:
The intended uses of the Spectra-System Abutments are identical to the intended use of the predicate implants. The included abutments are accessories to endosseous dental implants designed to support a prosthesis in the partially or fully endentulous mandible or maxilla. The laboratory components in this submission are used in a dental laboratory to aid in the fabrication of a final prosthetic appliance.
6. Device Comparison:
This submission is comprised of abutments whose physical dimensions, material composition, indications for use and methods of manufacture were previously approved and have the same principles of operation as the cited predicate devices. The differences between the components included in this submission and their predicate devise pose no new or additional issues of safety or effectiveness.
7030Malibu Hills Road CalabasasHills CA USA91301 -818.444.3317
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features an eagle with its wings spread, clutching a staff with a snake wrapped around it, which is a symbol of medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas Gottenbos Vice President of IT / Regulatory Affairs Implant Direct L.L.C. 27030 Malibu Hills Road Calabasas Hills, California 91301
JAN 1 4 2009
Re: K081101
Trade/Device Name: Spectra-System Abutments 2008 Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 22, 2008 Received: December 29, 2008
Dear Mr. Gottenbos:
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.
2
Page 2 - Mr. Gottenbos
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 vour 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 regarding 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 yours,
Susan Runnes
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
3
Indications for Use
510(k) Number (if known): Ko 8 110 (
Device Name: Spectra-System Abutments 2008
Indications for Use:
Spectra-System Abutments are designed to be used in support of a dental implant(s) to provide support for prosthetic restorations such as crowns, bridges, overdentures or custom prosthetic fabrications in a partially or completely edentulous patient. Spectra-System Abutments are intended for use in the mandible or maxilla. Prostheses can be screw or cement retained to the abutment.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rumer
(Division Sign-Off) Division of Anesthesiology, General Hospital Intection Control, Dental Devices
Page l of l
510(k) Number: Kas 1101.