(14 days)
Not Found
No
The summary describes a physical dental implant component made of PEEK and its intended use for protecting abutments and maintaining gingival contour. There is no mention of software, algorithms, or any computational processing, let alone AI/ML.
No.
The device, a dental implant component, serves a protective and supportive function for dental implants and abutments. It does not exert any therapeutic action on the body, such as treating or preventing a disease or condition.
No
This device is a protective cap used on dental implants to maintain gingival contour and protect the abutment, not to diagnose a medical condition.
No
The device description explicitly states the device is a physical component made from polyetheretherketone (PEEK), which is a material used for hardware.
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: The Thommen SPI® EASY Dental Implant Protective Cap is a physical component used in dental implant procedures. It is made of PEEK and is used to maintain gingival contour, protect the abutment, and protect the patient's tongue.
- Intended Use: The intended use is to be used in conjunction with dental implants to support crowns, bridges, or overdentures. This is a structural and protective function within the mouth, not a diagnostic test performed on a sample.
The device's function is entirely mechanical and related to the physical structure and protection within the oral cavity, which is not the domain of in vitro diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NHA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary and/or mandibular arch
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.)
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Page 1 of 2
NOV - 3 2003
ADMINISTRATIVE INFORMATION
.
.
| Manufacturer Name: | Thommen Medical AG
Hauptstrasse 87
CH-4437 Waldenburg
Switzerland
Telephone +41 61 965 90 20
FAX +41 61 965 90 21 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Orlando Antunes |
| Representative/Consultant: | Floyd G. Larson
PaxMed International
4329 Graydon Road
San Diego, CA 92130
Telephone: (858) 792-1235
FAX: (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.
1
PREDICATE DEVICE INFORMATION
.
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.
2
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _V
OR
Over-The-Counter Use
Susa Rumpf
(Division Sign-Off)
510(k) Number: