(90 days)
DESS® dental implants are indicated for surgical placement in the upper or lower jaw in edentulous or partially edentulous patients for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. They are designed to support single or multi-unit restorations in splinted or non-splinted applications, as well as to support overdenture attachment systems. DESS® dental implants may be used for immediate or early implantation following extraction or loss of natural teeth, and may be used for immediate or delayed loading techniques. Implants may be loaded immediately when good primary stability is achieved and occlusal loading is appropriate.
DESS® NEO GM Dental Implants are compatible with DESS® Dental Smart Solutions abutments having the identical NEO GM connection manufactured by Terrats Medical SL.
DESS® NEO GM Dental Implants with a diameter of 3.5 mm are indicated for use in reduced interdental spaces, where there is not enough alveolar bone for a larger diameter implant. The use of 3.5 mm implants is intended only for rehabilitation of the anterior region of the mouth.
DESS® Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.
All digitally designed custom abutments for use with DESS® Pre-Milled Blank abutments are to be sent to a Terrats Medical validated milling center for manufacture.
This submission includes dental implants that are compatible with DESS® Dental Smart Solutions abutments having the identical NEO GM connection manufactured by the sponsor of this submission, Terrats Medical SL, and cleared under K212628, K222288, K233316, K240208, and K242340. No claims of compatibility between the subject device implants and abutments from any OEM other than DESS® Dental Smart Solutions will be made. This submission also includes DESSLoc abutments that are compatible with eight (8) dental implant lines from five (5) OEM manufacturers. Also included in this submission is one (1) Pre-Milled Blank abutment that is compatible with three (3) implant lines manufactured by Alpha Dent Implants GmbH.
This submission includes one implant line, the Dental Implant NEO GM, a series of self-tapping, threaded, root-form dental implants to be placed at bone level. The subject device implants are provided in body diameters of 3.55 mm, 3.75 mm, 4.0 mm, 4.3 mm, 5.0 mm, 6.0 mm, and 7.0 mm. The subject device implant body diameters will be labeled as 3.5 mm, 3.75 mm, 4.0 mm, 4.3 mm, 5.0 mm, 6.0 mm, and 7.0 mm. Implant with body diameters ranging from 3.55 mm to 5.0 mm are provided in overall lengths of 7.9 mm, 9.9 mm, 11.4 mm, 12.9 mm, 15.9 mm, and 17.9 mm. Implants with body diameters 6.0 mm and 7.0 mm are provided in overall lengths of 7.9 mm, 9.9 mm, and 11.4 mm. The subject device implant lengths will be labeled as 8 mm, 10 mm, 11.5 mm, 13 mm, 16 mm, and 18 mm. All subject device implants, regardless of body diameter, have an internal Morse taper connection with a 16° included angle and 2.99 mm diameter opening at the top of the implant. This NEO GM connection is identical to the connection for abutments cleared previously in K242340.
All subject device implants are made of unalloyed titanium conforming ASTM F67 and ISO 5832-2. The entire endosseous surface, except for a small coronal bevel, features a grit blasted and double acid etched (SLA) surface, which is identical to the surface treatment for DESS® implants that were cleared in K212538.
This submission also includes DESSLoc Abutments designed for overdenture retention. The subject device DESSLoc Abutments are straight, non-engaging abutments that attach directly to the implant and are compatible with eight (8) dental implant lines from five (5) OEM manufacturers.
The subject device DESSLoc Abutments are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The subject device DESSLoc abutments have a zirconium nitride (ZrN) coating produced by a physical vapor deposition (PVD) process. The ZrN coating is applied to increase the surface hardness and reduce wear of the abutment surface. The ZrN coating for the subject device DESSLoc Abutments is identical to the ZrN coating applied to DESSLoc Abutments cleared in K242340, K240208, K222288, K191986, and K170588.
This submission also includes one (1) Pre-Milled Blank Abutment that is compatible with three (3) implant lines manufactured by Alpha Dent Implants GmbH, including Implant Active Konus, Implant Classic Konus, and Implant Active Bio, cleared in cleared in K210499. Reverse engineering compatibility analysis of the Alpha Dent implants, abutments, and abutment screws and Terrats Medical SL abutments and abutment screws was provided in the prior Terrats Medical SL submission K243212.
The Pre-Milled Blank Abutment has a maximum (before milling) diameter of 10 mm and a solid cylindrical design and an engaging implant connection. The Pre-Milled Blank Abutment is manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136. All patient-specific custom abutment fabrication for the Pre-Milled Blank Abutment is by prescription on the order of the clinician and will be done at a Terrats Medical validated milling center under FDA quality system regulations. The design parameters for the CAD-CAM fabrication of a custom abutment from the Pre-Milled Blank Abutment are:
- Minimum wall thickness – 0.45 mm
- Minimum post height for single-unit restoration – 4.0 mm (post height measured above the gingival height of the final patient-matched design)
- Minimum gingival height – 0.5 mm
- Maximum gingival height – 6.0 mm
- Pre-Milled Blanks are for straight abutments only
The abutment screw for use with the Pre-Milled Blank Abutment and the Alpha Dent implants was cleared previously in K243212.
All subject device implants are provided sterile, and all subject device abutments are provided non-sterile. The Pre-Milled Blank Abutment is supplied with the previously-cleared non-sterile abutment screw for attachment to the corresponding compatible implant. All subject device components are provided in single-unit packages for single-patient, single-use only.
The provided FDA 510(k) Clearance Letter for DESS® Dental Implants (K251280) does not contain information about acceptance criteria or a specific study proving the device meets those criteria in the context of AI/ML device performance.
The document is a clearance letter for a dental implant system, which is a physical medical device, not an AI/ML-driven diagnostic or treatment planning software. Therefore, the questions related to AI/ML device performance (such as sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth) are not applicable to the content provided.
The document primarily focuses on demonstrating substantial equivalence to predicate devices based on:
- Intended Use and Indications for Use
- Technological Characteristics (design, materials, surface treatment, sterilization methods, dimensions)
- Performance Data (non-clinical data such as MRI review, sterilization validation, bacterial endotoxin testing, shelf life, biocompatibility, and mechanical testing according to ISO 14801).
Since the request specifically asks for AI/ML-related performance evaluation, and the provided document is not for an AI/ML device, I cannot fulfill the request as stated with the given input.
However, I can extract the non-clinical performance data and the comparison to predicate devices, which serve as the "study" and "acceptance criteria" for this type of physical medical device in the context of a 510(k) submission.
Non-Clinical Performance Data (Serving as "Study" for Substantial Equivalence):
-
Worst-Case MRI Review:
- Method: Scientific rationale and published literature (T.O. Woods, J.G. Delfino, and S. Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices," Journal of Testing and Evaluation Volume 49, No. 2 (March/April 2021): 783–795).
- Scope: Evaluated all compatible implant bodies, abutments, and fixation screws and their material composition.
- Parameters: Magnetically induced displacement force and torque, per FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment."
- Outcome: Rationale addressed parameters; device components found suitable for the MR environment.
-
Gamma Irradiation Sterilization Validation (for implants):
- Method: Selecting and substantiating a 25 kGy dose using method VDmax25, according to ISO 11137-1 and ISO 11137-2.
- Acceptance Criteria: Sterility Assurance Level (SAL) of $10^{-6}$.
- Outcome: Analysis showed the subject device implants met the SAL and did not create a new worst case compared to predicate device K212538.
-
Bacterial Endotoxin Testing:
- Method: Limulus amebocyte lysate (LAL) testing according to ANSI/AAMI ST72.
- Acceptance Criteria: Limit of
§ 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.