(14 days)
The Thommen SPI® EASY Dental Implant Protective Cap is intended to be used in conjunction with SPI® System dental implants, which provide support for crowns, bridges or overdentures in the maxillary and/or mandibular arch.
The Thommen SPI® EASY Dental Implant Protective Cap is an endosseous dental implant component made from polyetheretherketone (PEEK). The Protective Cap may be used for maintaining the gingival contour, replacing or augmenting the use of the Gingiva Former. If it is used to augment the function of the Gingiva Former, it is placed after the Gingiva Former is removed and the abutment is placed, but before the final restoration is placed. The Protective Cap also serves to protect the coronal aspect of the abutment from damage and the patient's tongue from injury during the time the final restoration is being fabricated.
The Protective Cap will be offered in sizes to fitall SPI® EASY abutments and may be used with all SPI® System dental implants.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document describes a 510(k) premarket notification for a dental implant component, focusing on its substantial equivalence to a predicate device. It details administrative information, device description, intended use, and equivalence to a marketed product, but it does not include any performance metrics, study designs, or acceptance criteria relevant to the questions asked.
Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, adjudication methods, or comparative effectiveness studies.
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Page 1 of 2
NOV - 3 2003
ADMINISTRATIVE INFORMATION
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| Manufacturer Name: | Thommen Medical AGHauptstrasse 87CH-4437 WaldenburgSwitzerlandTelephone +41 61 965 90 20FAX +41 61 965 90 21 |
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| Official Contact: | Orlando Antunes |
| Representative/Consultant: | Floyd G. LarsonPaxMed International4329 Graydon RoadSan Diego, CA 92130Telephone: (858) 792-1235FAX: (858) 792-1236 |
DEVICE NAME
| Classification Name: | Abutment, Implant, Dental, Endosseous (NHA |
|---|---|
| Trade/Proprietary Name: | SPI® EASY Dental Implant Protective Cap |
| Common Name: | Endosseous Dental Implant System component |
ESTABLISHMENT REGISTRATION NUMBER
Thommen Medical AG has submitted an Establishment Registration to FDA. The Establishment Registration number is 3003836985. The Owner/Operator number is 9051144.
DEVICE CLASSIFICATION
FDA has classified endosseous dental implants as a Class III device (21 CFR 872.3640). The product code for "Abutment, Implant, Dental, Endosseous" is NHA.
CONFORMANCE WITH PERFORMANCE STANDARDS
No performance standards applicable to endosseous dental implant abutments have been established by FDA. The polyetheretherketone (PEEK) raw material from which the SPI® EASY Dental Implant Protective Cap is made complies with ASTM F2026.
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PREDICATE DEVICE INFORMATION
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The predicate device for this modification is the SPI® Dental Implant System Gingiva Former, cleared by FDA on July 2, 2003 under K031747 and on November 13, 2002 under K023645.
PACKAGING/LABELING/PRODUCT INFORMATION
Thommen SPI®EASY Dental Implant Protective Cap will be packaged and sold nonsterile. The device is not represented to be "pyrogen free."
INTENDED USE
The Thommen SPI® EASY Dental Implant Protective Cap is intended to be used in conjunction with SPI® System dental implants, which provide support for crowns, bridges or overdentures in the maxillary and/or mandibular arch.
DEVICE DESCRIPTION
The Thommen SPI® EASY Dental Implant Protective Cap is an endosseous dental implant component made from polyetheretherketone (PEEK). The Protective Cap may be used for maintaining the gingival contour, replacing or augmenting the use of the Gingiva Former. If it is used to augment the function of the Gingiva Former, it is placed after the Gingiva Former is removed and the abutment is placed, but before the final restoration is placed. The Protective Cap also serves to protect the coronal aspect of the abutment from damage and the patient's tongue from injury during the time the final restoration is being fabricated.
The Protective Cap will be offered in sizes to fitall SPI® EASY abutments and may be used with all SPI® System dental implants.
EQUIVALENCE TO MARKETED PRODUCT
The SPI® EASY Dental Implant Protective Cap has the following similarities to the predicate SPI® Dental Implant Gingiva Former:
- · has the same intended use.
- · uses the same operating principle,
- · incorporates the same basic design.
In summary, the Thommen SP1® EASY Dental Implant Protective Cap described in this submission is, in our opinion, substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings.
Public Health Service
NOV - 3 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Thommen Medical AG C/O Mr. Floyd G. Larson PaxMed International 4329 Graydon Road San Diego, California 92130
Re: K033346
Trade/Device Name: SPI® EASY Dental Implant Protective Cap Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: NHA Dated: October 17, 2003 Received: October 20, 2003
Dear Mr. Larson
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, Druz, 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. Larson
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 (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 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/dsma/dsmamain.html
Sincerely yours,
Pastora Cuente yfor
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
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Special 510(k): Device Modification
- SPI® EASY Dental Implant Protective Cap
Applicant: Thommen Medical AG
510(k) Number:
Device Name: SPI® EASY Dental Implant Protective Cap
Indications for Use:
The Thommen SPI® EASY Dental Implant Protective Cap is intended to be used in conjunction with SPI® System dental implants, which provide support for crowns, bridges or overdentures in the maxillary and/or mandibular arch.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _V
OR
Over-The-Counter Use
Susa Rumpf
(Division Sign-Off)
510(k) Number:
§ 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.)