(162 days)
The Simpler Toadstool Abutment consists of a pre-manufactured flattened ball which is directly screwed into a Simpler endosseous dental implant. The design allows for a lower profile height for a soft tissue supported overdenture. The prosthetic device is indicated for retention of soft tissue supported overdentures only and NOT for implant supported prostheses such as crowns and bridges.
The Toadstool abutment is a restorative prosthesis that threads into an already integrated dental implant. A rubber O ring snaps into a metal keeper, both of which are imbedded into a denture base. When in use, this rubber ring/keeper combination attaches the denture to the abutment preventing the movement of the denture while providing a cushioning affect to the implant.
It has a flattened ball at the top giving the retention area an ovoid appearance in profile. The external hexagonal portion of the abutment that allows the abutment to be torqued into the implant has been moved from below the ball at gingival level to the be part of the ovoid retention portion
The provided document is a 510(k) summary for the "Simpler Toadstool Abutment," a dental implant component. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a comprehensive clinical study with detailed performance metrics.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set specifics.
Here's a breakdown of why the requested information is absent:
- Acceptance Criteria and Reported Device Performance (Table 1): The document does not define specific clinical acceptance criteria (e.g., success rates, complication rates, retention force ranges) for a clinical trial and does not report performance against such criteria. It states that the device has "proven safe and effective" by reference to predicate devices but doesn't provide new performance data. The only "test" mentioned is a non-clinical torquing load test, which is an engineering specification, not a clinical performance metric.
- Sample Size for Test Set and Data Provenance (2): No clinical test set is described. The "non clinical tests" mentioned involve the device itself, not human subjects or patient data.
- Number of Experts and Qualifications for Ground Truth (3): Ground truth is not established in the context of clinical performance as no clinical study or expert review of clinical outcomes is described.
- Adjudication Method (4): Not applicable, as there's no clinical test set requiring adjudication.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study (5): Not applicable. This type of study would compare human performance with and without AI assistance, which is not relevant to a dental abutment's mechanical evaluation.
- Standalone Performance (6): The device's "performance" is primarily mechanical and related to its design modifications. It's not an AI algorithm with standalone performance in the typical sense. The torquing load test result could be considered a standalone mechanical performance, but it's not a comprehensive clinical performance metric.
- Reported performance (from "NON CLINICAL TESTS"): The abutments were tested to a breaking limit of 113 to 120 NCm. This is well in excess of the recommended maximum torquing load of 30 NCm for insertion.
- Type of Ground Truth Used (7): For the non-clinical test, the "ground truth" is the physical measurement of the breaking limit under controlled laboratory conditions. There is no clinical ground truth established or needed for this type of submission.
- Sample Size for Training Set (8): Not applicable. There is no AI model or algorithm being "trained."
- How Ground Truth for Training Set was Established (9): Not applicable.
Summary of what is provided regarding testing:
The document mentions non-clinical tests directly related to the mechanical properties of the abutment:
- Test: Torquing load on abutments during insertion.
- Acceptance Criterion (implicit): The device should withstand torquing loads significantly higher than the recommended insertion torque.
- Reported Performance: The abutments were tested to a breaking limit of 113 to 120 NCm.
- Conclusion: This breaking limit is well in excess of the recommended torque load of 30 NCm.
This information demonstrates the structural integrity of the abutment under a specific loading condition but does not involve clinical performance, human subjects, or AI evaluations. The primary argument for substantial equivalence relies on the device's design similarities to already approved predicate devices and the fact that its modifications (flattened ball, hex relocation) do not raise new questions of safety or effectiveness.
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Appendix A: 510(k) Summary: Simpler Toadstool Abutments
DATE OF PREPARATION: Tuesday, June 01, 2010
ADMINISTRATIVE INFORMATION
JUN - 4 2010
Manufacturer: Pan Global Implant Corp. #404 1023 Wolfe Ave. Vancouver, BC, Canada veh 1ve Telephone: 604 736 9890 Fax: 604 736 9747 E-Mail simpler@simplerimplants.com
Official Contact Dr. Harold Bergman or Mrs. Karen Bergman Address: same as above
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | Simpler Toadstool Abutment |
|---|---|
| Common Name | Dental implant o ring abutment |
| Classification Regulations: | Endosseous dental implant abutment21 CFR 872.3630, Class II |
| Product Code | NHA |
| Classification Name | Endosseous Dental Implant Abutment |
| Reviewing Branch: | Dental Devices Branch |
SUBSTANTIAL EQUIVALENCY TO MARKETED PRODUCT: As with most O Ring Abutment systems on the market today, the substantially equivalent predicated marketed devices include the use of a ball abutment, O rings, keepers, compatibility with the company's implants, intended use, indications for use and safety standards. Camlog K051636, Bicon K853733, Biomet and BioHorizons K990277, Implant Innovations K891613 are all approved O ring abutment systems which have proven safe and effective and substantially equivalent to the Simpler Toadstool Abutments.
There are two modifications to the traditional O ring Abutment design used by the predicate devices. The top portion of the Simpler Toadstool Abutment has a flattened ball giving the retention area an ovoid appearance in profile. The external hexagonal portion of the abutment that allows the abutment to be torque into the implant from below the ball at gingival level and incorporated as part of the ovoid ball. These two changes effectively lower the profile to of the abutment to 0.098″ above the gingiva. A rubber O ring is inserted into a metal keeper which in turn is imbedded into the denture base as with predicate devices.
The attachment portion of the Simpler Toadstool abutments are identical in all design aspects to the attachment portion of the Toadstool Mini Narrow Diameter implant K092674. The mating surface
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portion inserted into the implant is identical in all aspects to the mating surface portion inserted into the implant of the Simpler O ring Abutments and other Simpler Abutments.(i.e. Simpler Implants K974403, K060376, K974404, K974403). The in denture attachment portion of the Simpler Toadstool abutments are equivalent to the in denture attachment portion of the Simpler predicate devices listed above. All Simple Implant Abutments have the same Quality System (ISO 13485: 2003).
(i.e. Camlog K051636)
DEVICE DESCRIPTION: The Toadstool abutment is a restorative prosthesis that threads into an already integrated dental implant. A rubber O ring snaps into a metal keeper, both of which are imbedded into a denture base. When in use, this rubber ring/keeper combination attaches the denture to the abutment preventing the movement of the denture while providing a cushioning affect to the implant.
It has a flattened ball at the top giving the retention area an ovoid appearance in profile. The external hexagonal portion of the abutment that allows the abutment to be torqued into the implant has been moved from below the ball at gingival level to the be part of the ovoid retention portion
INDICATIONS:
The Simpler Toadstool Abutment consists of a pre-manufactured ball which is directly screwed into a Simpler endosseous dental implant. The design allows for a lower profile height for a soft tissue supported overdenture. This prosthetic device is indicated for retention of soft tissue supported overdentures only and NOT for implant supported prostheses such as crowns and bridges.
TECHNOLOGICAL CHARACTERISTICS: There are two modifications to the traditional O ring Abutment design used by the predicate devices. Instead of the traditional rounded ball, the top portion of the Simpler Toadstool Abutment has a flattened ball giving the retention area an ovoid appearance in profile.
Instead of the hexed shaped torquing portion of the abutment lying below the ball at the gingival level, the external hexagonal portion of the abutment that allows the abutment to be torque into the implant is moved and incorporated as part of the ovoid ball. These two changes effectively lower the profile to 0.098" above the gingival.
The neck portion of the abutment below the ball has been narrowed and elongated to allow the rubber ring and keeper to move apically thereby reducing the implant when in function.
NON CLINICAL TESTS: The torquing load on an abutments when inserting the abutment into the implant is recommended not to exceed 30NCm. The abutments have been tested to a breaking limit of 113 to 120 NCm. This limit is well in excess of recommended torque loads.
CONCLUSIONS OF TESTS: The only major change from equivalent predicated devices is the movement of the torquing hex from below the ball and incorporating it as part of the ball itself. The recommended forces (30NCm) used to tighten the abutment into the implant.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Dr. Harold Bergman ·Pan-Global-Implant- · · · · · · · · · · #404 1023 Wolfe Avenue Vancouver, BC Canada V6H 1V6
JUN - 4 2010
Re: K093975
Trade/Device Name: Simpler Toadstool Abutment, Model S19000-S19009 Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 14, 2010 Received: May 18, 2010
Dear Dr. Bergman:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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Page 2- Dr. Harold Bergman
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mr 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
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Indications for Use
510(k) Number (if known): K093975
Device Name: Simpler Toadstool Abutnent
Indications For Use:
The Simpler Toadstool Abutment consists of a pre-manufactured flattened ball which is directly screwed into a Simpler endosseous dental implant. The design allows for a lower profile height for a soft tissue supported overdenture. The prosthetic device is indicated for retention of soft tissue supported overdentures only and NOT for implant supported prostheses such as crowns and bridges.
Prescription Use Yes Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use No (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)
Rshatingsajin M. K.P. Muly
vision of Anesthesiology, General Hospital fection Control, Dental Devices
?(k) Number: K093975
§ 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.)