(186 days)
The Piccolo Implants and Accessories are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:
• replacing maxillary lateral incisors and mandibular incisors,
• immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge,
• immediate loading when good primary stability with appropriate occlusal loading is achieved, except in soft bone (type IV) where implant stability may be difficult to obtain.
The Piccolo Implants and Accessories is a threaded root-form dental implant and abutment system.
The implants are Ø3.0 mm in diameter with lengths of 8.5, 10, 11.5, 13 and 15 mm. There is a standard version and a MSC version with a 1 and 3 mm machined surface coronal region respectively. The rest of the body has a roughened surface. The system has an external hexagonal implant-abutment interface.
The following abutments are included in the range: Cover Screws, Healing Abutments (all made from commercially pure titanium (CPTi)), Gold Abutments (made from gold alloy), Passive Abutments and Compact Conical Abutments (both made from titanium alloy). All abutments (except the onepiece abutments) are used with a titanium alloy retaining screw.
The provided text is a 510(k) summary for a medical device (Piccolo Implants and Accessories) and details its substantial equivalence to predicate devices. It does not describe an acceptance criteria and study as typically conducted for performance claims of AI/ML or diagnostic devices. Instead, it focuses on non-clinical performance and material equivalence.
Therefore, many of the requested categories for acceptance criteria and study details cannot be directly extracted from this document, as the submission relies on demonstrating substantial equivalence through engineering analysis, dimensional analysis, dynamic compression-bending tests, and material/sterilization/packaging equivalence to predicates, rather than a clinical performance study with human readers, AI assistance, or expert ground truth.
However, I can extract the information that is present concerning performance data and equivalence.
Acceptance Criteria and Device Performance (Based on Non-Clinical Data)
| Acceptance Criteria Category | Reported Device Performance / Method of Proof |
|---|---|
| Material Equivalence | The device is manufactured from the same material (CPTi - cold worked for implants, CPTi, Titanium alloy, Gold alloy for abutments) using the same manufacturing method as predicate devices (K163060, K163634). Biocompatibility is also established in accordance with ISO 10993-1 and ISO 10993-5 (Cytotoxicity testing) for the same materials. |
| Dimensional & Design Equivalence | The implants are Ø3.0 mm in diameter with lengths 8.5, 10, 11.5, 13, and 15 mm, with an external hexagonal implant-abutment interface, and have both standard and MSC versions with varying machined surface coronal regions. This was compared to the primary predicate (K163060) which also has Ø3.0 implants, and a reference device (K163634) which has Ø3.25 tapered implants with similar shape, lengths, thread, flutes, taper, apex, collar, and connection interface. Dimensional analysis was performed. |
| Mechanical Performance | Dynamic compression-bending to ISO 14801 (Dentistry - Implants - Dynamic fatigue test for endosseous dental implants) was performed. No specific performance metrics (e.g., fatigue cycles, load limits) are presented in this summary, but the test was used to demonstrate equivalence. |
| Sterilization | The sterilization method (Gamma radiation) is the same as predicate devices (K163060, K163634) and was validated per ISO 11137-1 and ISO 11137-2. Moist heat sterilization for end-user sterilized devices was validated per ISO 17665-1 and ISO 17665-2. The Limulus Amebocyte Lysate (LAL) test for bacterial endotoxin (USP 39-NF 34 <85>) was conducted. |
| Packaging & Shelf Life | Packaging is the same as predicate devices and was validated per ISO 11607. Accelerated aging per ASTM-F-1980 was applied to substantiate a 5-year shelf life. |
Study Details (Based on Information Provided)
-
Sample size used for the test set and the data provenance: Not applicable. This submission relies on non-clinical tests (engineering analysis, dimensional analysis, dynamic compression-bending tests, biocompatibility testing, sterilization validation, packaging validation) and comparison to predicate devices, not a clinical "test set" of patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring expert ground truth was performed for this 510(k) submission.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set requiring adjudication was performed.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a submission for a dental implant and accessories, which are physical medical devices, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of clinical "ground truth." For non-clinical tests, "ground truth" would correspond to established engineering standards (e.g., ISO 14801 for fatigue testing, ISO 11137 for sterilization) and established material properties, which serve as the reference for successful performance.
-
The sample size for the training set: Not applicable. This is not an AI/ML device submission.
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How the ground truth for the training set was established: Not applicable. This is not an AI/ML device submission.
Summary of what was done:
The submission uses non-clinical data including:
- Engineering analysis
- Dimensional analysis
- Dynamic compression-bending tests to ISO 14801 for mechanical performance.
- Biocompatibility testing to ISO 10993-1 and ISO 10993-5.
- Sterilization validation to ISO 11137-1, ISO 11137-2, ISO 17665-1, and ISO 17665-2, and bacterial endotoxin testing (USP 39-NF 34 <85>).
- Packaging validation to ISO 11607 and accelerated aging per ASTM-F-1980 to demonstrate a 5-year shelf life.
The primary method of demonstrating device performance and meeting the implicit "acceptance criteria" of safety and effectiveness for a 510(k) submission is through "substantial equivalence" to legally marketed predicate devices, particularly K163060 (Southern Implants Deep Conical Implants and Accessories) and K163634 (Southern Implants External Hex Implants and Accessories), and K120414 (Astra Tech AB OsseoSpeed™ Plus). The submission highlights that the subject device shares the same intended use, similar technological characteristics, same materials, manufacturing methods, sterilization methods, and packaging as the predicate devices.
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Southern Implants (Pty) Ltd. Lauranda Breytenbach Regulatory Affairs and Quality 1 Albert Road Irene, Gauteng 0062 SOUTH AFRICA
Re: K173706
Trade/Device Name: Piccolo Implants and Accessories Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: March 19, 2018 Received: March 23, 2018
Dear Lauranda Breytenbach:
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.
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 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);
June 8, 2018
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Mary S. Runner -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, 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) K173706
Device Name Piccolo Implants and Accessories
Indications for Use (Describe)
The Piccolo Implants and Accessories are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:
· replacing maxillary lateral incisors and mandibular incisors,
· immediate placement in extraction situations with a partially or completely healed alveolar ridge,
· immediate loading when good primary stability with appropriate occlusal loading is achieved, except in soft bone (type IV) where implant stability may be difficult to obtain.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Piccolo Implants and Accessories
Southern Implants (Pty)
Ltd. June 8, 2018
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Southern Implants (Pty) Ltd.1 Albert RoadIrene, Gauteng, 0062 South Africa |
|---|---|
| Telephone + 27 12 667 1046Fax + 27 12 667 1029 | |
| Official Contact | Lauranda BreytenbachRegulatory Affairs and Quality |
| DEVICE NAME AND CLASSIFICATION | |
| Trade/Proprietary Name | Piccolo Implants and Accessories |
| Common Name | Dental implantDental implant abutment |
| Classification Name | Endosseous dental implantEndosseous dental implant abutment |
| Classification Regulations | 21 CFR 872.3640, Class II |
| Product Code | DZE (Primary product code)NHA (Secondary product code) |
Classification Panel Dental Products Panel Reviewing Branch Dental Devices Branch
PREDICATE DEVICE INFORMATION
| Manufacturer | Device Name | K number | |
|---|---|---|---|
| Primary: | Southern Implants (Pty) Ltd. | Deep Conical (DC) Implants and Accessories | K163060 |
| Reference: | Southern Implants (Pty) Ltd. | External Hex Implants and Accessories | K163634 |
| Reference: | Astra Tech AB | OsseoSpeed™ Plus | K120414 |
INDICATIONS FOR USE
The Piccolo Implants and Accessories are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:
- replacing maxillary lateral incisors and mandibular incisors,
- immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge,
- immediate loading when good primary stability with appropriate occlusal loading is achieved, except ● in soft bone (type IV) where implant stability may be difficult to obtain.
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The Piccolo Implants and Accessories is a threaded root-form dental implant and abutment system.
The implants are Ø3.0 mm in diameter with lengths of 8.5, 10, 11.5, 13 and 15 mm. There is a standard version and a MSC version with a 1 and 3 mm machined surface coronal region respectively. The rest of the body has a roughened surface. The system has an external hexagonal implant-abutment interface.
The following abutments are included in the range: Cover Screws, Healing Abutments (all made from commercially pure titanium (CPTi)), Gold Abutments (made from gold alloy), Passive Abutments and Compact Conical Abutments (both made from titanium alloy). All abutments (except the onepiece abutments) are used with a titanium alloy retaining screw. An overview is given in Table 1.
| Abutment Model | Type | Body/gingivalheight | Platform Ø | Body Ø |
|---|---|---|---|---|
| Cover Screws | One-piece | 1.2 | Ø3.0 | Ø3.0 |
| Healing Abutments | One-piece Narrow | 3, 4, 6 | Ø3.0 | Ø3.0 |
| One-piece Wide | 3, 4, 6 | Ø3.0 | Ø4.0 | |
| Titanium Abutments | Engaging | 1 | Ø3.5 | |
| Non-engaging | 1 | Ø3.0 | ||
| Gold Abutments | Engaging | 0.75 | Ø3.5 | |
| Non-engaging | 0.75 | Ø3.0 | ||
| Passive Abutments | Engaging | 0.6 | Ø3.5 | |
| Non-engaging | 0.6 | Ø3.0 | ||
| Engaging (Vertical) | 1.0 | Ø3.0 | ||
| Compact Conical Abutments | One-piece | 1.7, 3, 4, 5.5 | Ø3.0 | Ø4.8 |
Table 1: List of Abutments Included in the Subject Device
PERFORMANCE DATA
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include:engineering analysis, dimensional analysis, and dynamic compression-bending to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. No clinical data were included in this submission.
The sterilization method for the subject device is the same as the primary predicate (K163060) and reference device (K163634). The sterilization method is Gamma radiation and has been validated in accordance with ISO 11137-1 Sterilization of health care products - radiation - part 2: Requirements for development, validation, and routine control of a sterilization process for medical devices and ISO 11137-2 Sterilization of health care products - radiation - part 1: establishing the sterilization dose. The sterilization method is moist heat for the devices to be end user sterilized and has been validated in accordance with ISO 17665-1 Sterilization of health care products -- Moist heat -- Part 1: Reguirements for the development, validation and routine control of a sterilization process for medical devices and ISO 17665-2 Sterilization of health care products -- Moist heat -- Part 2: Guidance on the application of ISO 17665-1 . The Limulus Amebocyte Lysate (LAL) test for detection and quantitation of bacterial endotoxin was conducted in accordance with USP 39-NF 34 <85> Bacterial Endotoxin Test, using the kinetic chromogenic test method.
The packaging for the subject device is the same as the primary predicate (K163060) and reference device (K163634). Packaging was validated in accordance with ISO 11607 Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems. Accelerated aging per ASTM-F-1980 Standard guide for accelerated aging of sterile medical device packages has been applied on the final packaging followed by validating durability to peel and dye tests conditions, in order to substantiate 5 years shelf life.
The subject device is manufactured from the same material using the same manufacturing method as the applicant's own primary predicate (K163060) and reference device (K163634), has the same intended use, and the same patient contact type and duration.
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The subject device is biocompatible in accordance with ISO 10993-1. Cytotoxicity testing in accordance with ISO 10993-5 was also performed.
EQUIVALENCE TO MARKETED DEVICE
Southern Implants (Pty) Ltd submits the information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the subject device is substantially equivalent in indications and design principles to the following legally marketed predicate devices:
K163060, Southern Implants (Pty) Ltd., Deep Conical (DC) Implants and Accessories
K163634, Southern Implants (Pty) Ltd., External Hex Implants and Accessories
K120414, Astra Tech AB, OsseoSpeed™ Plus
A table comparing the subject device and primary predicate devices is provided in Table 2.
| Subject Device | Primary Predicate | |
|---|---|---|
| Submission name | Piccolo Implant and Accessories | Deep Conical (DC) Implants and Accessories |
| Manufacturer | Southern Implants (Pty) Ltd. | Southern Implants (Pty) Ltd. |
| 510(k) Number | K163060 | |
| Indications for Use Statement | The Piccolo Implants and Accessories areintended for both one- and two-stagesurgical procedures in the followingsituations and with the following clinicalprotocols:• replacing maxillary lateral incisors andmandibular incisors,• immediate placement in extraction sitesand in situations with a partially orcompletely healed alveolar ridge,• immediate loading when goodprimary stability with appropriateocclusal loading is achieved, except insoft bone (type IV) where implantstability may be difficult to obtain. | Southern Implants Dental Implants are intended for bothone- and two-stage surgical procedures in the followingsituations and with the following clinical protocols:• replacing single and multiple missing teeth in themandible and maxilla,• immediate placement in extraction sites and insituations with a partially or completely healed alveolarridge,• immediate loading in all indications, except in singletooth situations on implants shorter than 8mm or insoft bone (type IV) where implant stability may bedifficult to obtain and immediate loading may not beappropriate.The intended use for 3.0 Deep Conical implants is limitedto replacement of maxillary lateral incisors andmandibular incisors |
| Product Code | DZE, NHA | DZE, NHA |
| Intended Use | Dental implant system for the functionaland esthetic replacement of missing teeth. | Dental implant system for the functional and estheticreplacement of missing teeth. |
| Implant Body Design | Threaded root-form implants:Tapered | Threaded root-form implants:TaperedCylindricalCo-axis taperedCo-axis cylindrical |
| Implant body diameters andlengths (mm) | $Ø$ 3.0: length 8.5, 10, 11.5, 13, 15 | $Ø$ 3.0: length 9, 11, 13, 15$Ø$ 3.5 – $Ø$ 5.0: length 6 – 15 |
| Implant Material | CPTi - (cold worked) | CPTi – (cold worked) |
| Implant Surface | Southern Implants' roughened surfaceMachined collar versions available | Southern Implants' roughened surface |
| Implant Sterilization | Sterile — irradiation | Sterile — irradiation |
| Implant / Abutment Interface | External Hex | Deep Conical |
| Abutment Designs | Cover screwHealing abutment | Cover ScrewHealing Abutment, Healing Caps |
| Subject Device | Primary Predicate | |
| Titanium AbutmentGold AbutmentPassive AbutmentsCompact Conical Abutment | Titanium Abutment, Angled AbutmentsOverdenture AbutmentGold AbutmentPassive AbutmentsCompact Conical Abutment | |
| Abutment platform diameters | Ø3.0 | Ø3.0, Ø3.5, Ø4.0, Ø5.0 |
| Abutment angle | 0° only | 0°, 12°, 24° |
| Abutment Material | CPTiTitanium alloyGold alloy | CPTiTitanium alloyGold alloy |
| Abutment Surface | MachinedKnurled (grooved)Titanium nitride coated | MachinedKnurled (grooved)Titanium nitride coated |
| Restoration | Single-unit or multi-unit | Single-unit or multi-unit |
Table 2: Predicate 1 and Subject Device Comparison Table
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Primary predicate (K163060) is for substantial equivalence of the diameter, materials and surface of the implants and abutments. The subject device implants have the same outer diameter as the primary predicate Ø3.0 implants. The subject device is made from the same manufacturing facilities, with the same surface treatment as implants in primary predicate (K163060). The subject device has Ø3.0 abutments of the same type as the primary predicate (K163060) with substantially equivalent design and materials. Primary predicate (K163060) has implants with a range of sizes including diameter 3.0 mm implants. The subject device only has diameter 3.0 mm implants. The differences in wording of the indications for use statement reflect this difference, but with regards to the Ø3.0 implant and accessories the indications for use statements are substantially equivalent.
Reference device (K163634) is for substantial equivalence of the subject device implants and abutments. The subject device Piccolo implants are Ø3.0 tapered implants with a similar shape. lengths, thread, flutes, taper, apex, collar and connection interface to the corresponding Ø3.25 tapered implant in reference device (K163634).
The subject device and all primary predicate (K163060) and reference devices (K163634, K120414) are provided sterile for single-patient, single-use.
Substantial equivalence of the subject device components in terms of biocompatibility is supported by the fact that materials are identical in formulation, processing, component interactions, and storage conditions to the devices in primary predicate (K163060) and reference device (K163634).
CONCLUSION
The subject device and the primary predicate (K163060) and reference devices (K163634, K120414) have the same intended use, have similar technological characteristics, and are made of the same materials. The subject device and the primary predicate (K163060) and reference devices (K163634, K 120414) are packaged in similar materials and sterilized using similar methods.
The data included in this submission demonstrate substantial equivalence of the subject device to the primary predicate and reference devices listed above.
§ 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.