(72 days)
Not Found
No
The summary describes a physical dental implant and its intended use, with no mention of software, algorithms, or any technology related to AI or ML.
No
The device is a dental implant, which is a prosthetic device used to replace missing teeth, not to treat or cure a disease or condition.
No
This device, a dental implant, is intended for surgical placement in the bone to support dental prostheses. Its function is to provide physical support, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a threaded, tapered, endosseous dental implant made of commercially pure titanium, which is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a dental implant intended for surgical placement in bone to support dental prosthetics. This is a surgical device, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical implant made of titanium, designed for surgical implantation. This aligns with a medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This dental implant does not fit that description.
N/A
Intended Use / Indications for Use
The Thommen SPI® CONTACT Dental Implant is intended to be surgically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges, or overdentures. SPI® CONTACT implants can provide support for crowns, bridges, and overdentures. SPI® CONTACT implants can be loaded immediately in the mandibular arch if they are splinted with a bar on four implants in the mandibular arch or six implants in the maxillary arch.
Contraindications for the use of SPI® CONTACT implant ø 3.5 mm: These implants are not suitable for applications in areas where pronounced rotation and translation movements occur, causing the implant to be subjected to large bending moments.
- Restoration of posterior teeth in the upper or lower jaw
- Single-tooth restoration of canines and central incisors in the upper jaw
- Any application involving retentive anchors
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
Thommen SPI® CONTACT Dental Implants are threaded, tapered, endosseous dental implants made of commercially pure titanium and intended for use with the System abutments and instruments. The implants are offered in lengths ranging from 9.5 mm to 17 mm, with diameters from 3.5 mm to 6 mm.
SPI® CONTACT Dental Implants are made of pure titanium according to ASTM F 67 Grade 4/ ISO 5832-2 GR4B. The surface of the threaded portion of the SPI® Crado increating lant is sandblasted and acid etched. The 1.5 mm collar is smooth machined for subgingival and transgingival use.
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.
K003045, K022038, K030689, K030007, K964220, K022562
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
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
MAR - 5 2004
SPI® CONTACT Dental Implant 510(k) Summary "
Page 1
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 |
Floyd G. Larson Representative/Consultant: PaxMed International 4329 Graydon Road San Diego, CA 92130 Telephone (858) 792-1235 FAX (858) 792-1236
DEVICE NAME
| Classification Name: | Implant, Dental, Endosseous (DZE) |
|---|---|
| Trade/Proprietary Name: | SPI® CONTACT Dental Implant |
| Common Name: | Endosseous Dental Implant |
ESTABLISHMENT REGISTRATION NUMBER
The Establishment Registration number for Thommen Medical AG 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 "Implant, Dental, Endosseous" is DZE.
CONFORMANCE 'WITH PERFORMANCE STANDARDS
No performance standards applicable to endosseous dental implants have been No performanoo otandardo application Grade 4 used to manufacture Thommen outdental implants meet the chemical and mechanical requirements of ASTM F 67 and ISO 5832-2.
1
PACKAGING/LABELING/PRODUCT INFORMATION
Thommen SPI® CONTACT Dental Implants will be packaged in a radiation Thommen of I - OON AG+ Schulization will be accomplished by means of Co° gamma irradiation at a nominal dose of 25 kGy (2.5 Mrad). Sterilization will be validated by the bioburden method, according to ISO 11137 (Sterilization of Health Care Products – Radiation Sterilization). The sterility assurance level (SAL) that Frouncts - Nation Forent Editor meet for the SPI® CONTACT Dental Implant is 10-6. The device is not represented to be "pyrogen free."
INTENDED USE
The Thommen SPI® CONTACT Dental Implant is intended to be surgically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch to entificalluly of dollayou, in dollayou, in an overdentures. SPI® CONTACT implants can provide oupporter. Sily if they are splinted with a bar on four implants in the mandibular arch or six implants in the maxillary arch.
Contraindications for the use of SPI® CONTACT implant ø 3.5 mm: Oontraindloadons in in tsuitable for applications in areas where pronounced rotation and translation movements occur, causing the implant to be subjected to large bending moments.
- Restoration of posterior teeth in the upper or lower jaw -
- Single-tooth restoration of canines and central incisors in the upper jaw 【
- Any application involving retentive anchors -
DEVICE DESCRIPTION
Design Characteristics
Thommen SPI® CONTACT Dental Implants are threaded, tapered, endosseous dental implants made of commercially pure titanium and intended for use with the System abutments and instruments. The implants are offered in lengths ranging from 9.5 mm to 17 mm, with diameters from 3.5 mm to 6 mm.
Material Composition
SPI® CONTACT Dental Implants are made of pure titanium according to ASTM F 67 Grade 4/ ISO 5832-2 GR4B. The surface of the threaded portion of the SPI® Crado increating lant is sandblasted and acid etched. The 1.5 mm collar is smooth machined for subgingival and transgingival use.
2
EQUIVALENCE TO MARKETED PRODUCT
For the purposes of FDA's regulation of medical devices, the SPI® CONTACT Dental I or the purpose of the revivalent in indications and design principles to the implant is Substantially oquivalorit it in Dental Implant System, cleared by FDA on following predications and July 12, 2001 under K003045; the Thommen SPI® Onetime Dental Implant, cleared on July 15, 2002 under K022038; the Or | Onounts Dental Implant, cleared on March 4, 2003 under K030689; the Straumann ITI TE Dental Implant, cleared on March 31, 2003 under K030007; the Steri-Oss Replace Dental Implant cleared on March 5, 1997 under K964220 and the Bränemark Replace Select Dental Implant, cleared on October 11, 2002 under K022562.
The SPI® CONTACT Dental Implant has the following similarities to the predicate devices:
- · has the same intended use,
- · uses the same operating principle,
- · incorporates the same basic design,
- · incorporates the same materials, and
- · is packaged and sterilized using the same materials and processes.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 5 2004
Thommen Medical, AG C/O Ms. Floyd G. Larson President Paxmed International 4329 Graydon Road San Diego, California 92130
Re: K034014
Trade/Device Name: SPI Contact dental Implant Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: December 22, 2003 Received: December 24, 2003
Dear Ms. Larson:
We have reviewed your Scction 510(k) premarket notification of intent to market the device we have reviewed your and have determined the device is substantially equivalent (for the If it it cations 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinent, or to arrived Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents or a registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Wry, it har ob subject to case of Federal Regulations, Title 21, Parts 800 to 898. In your device can be fourther announcements concerning your device in the Federal Register.
4
Page 2 - Ms. Falk
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisou that 1127 - 166aailes on that your device complies with other requirements Incall that i 27 mas made a december and regulations administered by other Federal agencies. of the Act of any I oderal bate and separements, including, but not limited to: registration r our must comply with an the Hood ing (21 CFR Part 801); good manufacturing practice allu listing (21 CF R Part 807), and ity systems (QS) regulation (21 CFR Part 820); and if requirements as sections in the quarty sion 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 w your be even finding of substantial equivalence of your device to a premarket notification. - to 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), If you desire specific at 100 to 100 loss 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,
Clus
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
5
Indications for Use
510(k) Number (if known): K034014
Device Name: SP1® CONTACT Dental Implant
Indications For Use:
The Thommen SPI® CONTACT Dental Implant is intended to be surgically placed, either The Thomment SFI® CONTAOT Dentar Instillation or mandibular arch to provide support for
immediately or delayed, in the bone of the maxillary or mandibular if immediately of delayed, in the bono of the makinaly opplants can be loaded immediately in the crowns, brouges of overdentures: OF IC CONTATIO Filmplants in the maxillary arch.
Contraindications for the use of SPI® CONTACT implants Ø 3.5 mm:
Contrainalcations for the use of OF IO of to of the pronounced rotation and These Implants are not sultable for applications in threas miected to large bending moments.
translation movements occur, causing the implant to be subjected to large bendin
- ranblation of posterior teeth in the upper or lower jaw - Restoration of posterior tooth in the apper in the upper jaw
- Any application involving retentive anchors.
Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suger Rume
Division of Anesthesiology, General Hospital, Infection Control, Dental Dev
510(k) Number: K031014
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