(268 days)
No
The summary describes a physical surgical guide designed based on a digital plan, with no mention of AI or ML in the design or function.
No.
The device is a surgical guide designed to assist in the placement of dental implants and does not directly treat or prevent a disease or condition.
No
The device is a surgical guide used for assisting in the placement of dental implants, not for diagnosing medical conditions.
No
The device description explicitly states that the Simplant® Digital Guide is a physical surgical template fabricated using specific materials (resin, adhesive) and equipment (3D printer, washing/curing equipment). While it is designed using software, the final device is a physical object.
Based on the provided information, the Simplant® Digital Guide is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Intended Use: The Simplant® Digital Guide's intended use is to assist in the placement of dental implants during a surgical procedure. It is a physical guide used directly on the patient's oral anatomy.
- Device Description: The description clearly states it's a "patient specific surgical template" that "sits on the patient's oral anatomy." It's a tool for guiding a surgical procedure, not for analyzing biological specimens.
The device is a surgical guide, which falls under the category of medical devices used for surgical planning and execution, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Simplant® Digital Guide is a surgical guide intended for use in assisting in the placement of dental implants. The Simplant® Digital Guide is designed centrally by the Simplant® planning software and manufactured locally using Formlabs Dental SG resin, Locite 4304 adhesive, and Formlabs equipment: Form 2 printer, FormWash and FormCure washing and post-curing equipment.
Product codes
NDP
Device Description
The Simplant® Digital Guide is intended for use in assisting placement of dental implants.
The subject Simplant® Digital Guide is a patient specific surgical template, which is designed according to the digital pre-operative plan of the dental implant positions. The clinician, or dental lab, orders a digital design file of the surgical quide (i.e. Simplant® Guide File) which is developed under the same process that is utilized to produce the design of the predicate Simplant® Guide (K170849). The subject Simplant® Digital Guide is then fabricated locally by the clinician or dental lab, utilizing stereolithography fabrication method. The subject Simplant® Digital Guide is intended to be fabricated using Dental SG acrylic resin, Form 2 SLA 3D printer, and FormWash and FormCure washing and post-curing equipment manufactured by Formlabs, Inc.
The Simplant® Digital Guide sits on the patient's oral anatomy, i.e. teeth, mucosa or combination thereof. Aided by the Simplant® Digital Guide, the implant sites can be prepared, and the dental implants can be placed in the predetermined locations according to the previously pre-operative dental implant treatment plan.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's oral anatomy, i.e. teeth, mucosa or combination thereof
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician or dental lab
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
Bench Testing:
- Tube fixation test - push out. Sample size not specified. Ensures the device withstands typical vertical loads during surgery.
- Tube fixation test - torque. Sample size not specified. Ensures the device withstands occasional torque loads during surgery.
- Strength test. Sample size not specified. Ensures compliance with ISO 20795-1:2013-1 for dental materials.
- Angulation deviation test. Sample size not specified. Ensures manufacturing according to pre-operative plan regarding guide sleeve angular position.
- Position deviation test. Sample size not specified. Ensures manufacturing according to pre-operative plan regarding guide sleeve spatial position.
- Vertical fit test. Sample size not specified. Ensures manufacturing according to pre-operative plan regarding vertical position. Updates design process to
increase safety margin. - Additive manufacturing process variables were validated for build location, build orientation, print layer thickness, and raw material reuse. Strength test, tube fixation (pushout and torque), angulation deviation, position deviation, and vertical fit tests were conducted on samples from at least 3 build runs to confirm process variables do not affect finished device conformance.
Biocompatibility Testing:
- Assessment and testing based on ISO 10993-1:2009 and ISO 7405:2008. Concluded that the device meets criteria for biocompatibility.
Sterilization Validation:
- Updated steam sterilization parameters validated according to ISO 17665-1:2006 and ISO 17665-2:2009. Demonstrated a sterility assurance level (SAL) of 10-9.
Shelf Life Testing:
- Bench testing executed on samples that were sterilized and subjected to real-time aging for 2 weeks to ensure performance through the claimed shelf life of 2 weeks.
Clinical Performance Data:
- No data from human clinical studies has been included to support the substantial equivalence.
Key Results: Non-clinical performance testing, in combination with an updated design process, supports substantial equivalence of the subject device to the predicate. The device has identical Indications for Use, exhibits identical fundamental design features and similar principles of operation as the predicate.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3980 Endosseous dental implant accessories.
(a)
Identification. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour. These devices include drill bits, screwdrivers, countertorque devices, placement and removal tools, laboratory pieces used for fabrication of dental prosthetics, and trial abutments.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
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September 2, 2020
Dentsply Sirona Karl Nittinger Vice President Corporate Regulatory Affairs 221 West Philadelphia Street, Suite 60W York, Pennsylvania 17401
Re: K193405
Trade/Device Name: Simplant® Digital Guide Regulation Number: 21 CFR 872.3980 Regulation Name: Endosseous Dental Implant Accessories Regulatory Class: Class I Product Code: NDP Dated: July 30, 2020 Received: July 31, 2020
Dear Karl Nittinger:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193405
Device Name Simplant® Digital Guide
Indications for Use (Describe)
The Simplant® Digital Guide is a surgical guide intended for use in assisting in the placement of dental implants. The Simplant® Digital Guide is designed centrally by the Simplant® planning software and manufactured locally using Formlabs Dental SG resin, Locite 4304 adhesive, and Formlabs equipment: Form 2 printer, FormWash and FormCure washing and post-curing equipment.
| 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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Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
Image /page/3/Picture/2 description: The image contains the logo for Dentsply Sirona. The logo consists of a stylized leaf-like shape on the left, followed by the text "Dentsply" on the top line and "Sirona" on the bottom line. The text is in a simple, sans-serif font and is aligned to the right of the leaf-like shape.
510(k) SUMMARY
for K193405 Simplant® Digital Guide
Submitter Information: Dentsply Sirona
221 West Philadelphia Street Suite 60W York, PA 17401
| Contact Person:
Telephone Number:
Fax Number:
Email: | Karl Nittinger
717-849-4424
717-849-4343
karl.nittinger@dentsplysirona.com |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Date Prepared: | 02-September-2020 |
| Device Name:
• Proprietary Name: | Simplant® Digital Guide |
| • Classification Name:
• CFR Number:
• Device Class: | Endosseous Dental ImplantAccessories
• 21 CFR 872.3980
• Class I |
NDP
Predicate Device:
.
Product Code:
| Predicate Device
| Name | 510(k) | Company Name |
|---|---|---|
| Simplant® Guide | K170849 | Dentsply Sirona |
Description of Device:
The Simplant® Digital Guide is intended for use in assisting placement of dental implants.
The subject Simplant® Digital Guide is a patient specific surgical template, which is designed according to the digital pre-operative plan of the dental implant positions. The clinician, or dental lab, orders a digital design file of the surgical quide (i.e. Simplant® Guide File) which is developed under the same process that is utilized to produce the design of the predicate Simplant® Guide (K170849). The subject Simplant® Digital Guide is then fabricated locally by the clinician or dental lab, utilizing stereolithography fabrication method. The subject Simplant® Digital Guide is intended to be fabricated using Dental SG acrylic resin, Form 2 SLA 3D printer, and FormWash and FormCure washing and post-curing equipment manufactured by Formlabs, Inc.
4
The Simplant® Digital Guide sits on the patient's oral anatomy, i.e. teeth, mucosa or combination thereof. Aided by the Simplant® Digital Guide, the implant sites can be prepared, and the dental implants can be placed in the predetermined locations according to the previously pre-operative dental implant treatment plan.
Indications for Use:
The Simplant® Digital Guide is a surgical quide intended for use in assisting in the placement of dental implants. The Simplant® Digital Guide is designed centrally by the Simplant® planning software and manufactured locally using Formlabs Dental SG resin, Loctite 4304 adhesive, and Formlabs equipment: Form 2 printer, FormWash and FormCure washing and post-curing equipment.
Substantial Equivalence:
Technological Characteristics.
An overview of the similarities and differences between the subject and predicate devices are given in Table 5.1.
5
| Table 5.1-Similarities and Differences | |||
|---|---|---|---|
| Element | Subiect Device | ||
| Simplant® Digital Guide | Predicate Device | ||
| Simplant® Guide | |||
| (K170849) | Similarities and Differences | ||
| Indications for | |||
| Use | The Simplant® Digital Guide is a | ||
| surgical guide intended for use in | |||
| assisting in the placement of | |||
| dental implants. The Simplant® | |||
| Digital Guide is designed centrally | |||
| by the Simplant® planning | |||
| software and manufactured | |||
| locally using Formlabs Dental SG | |||
| resin, Loctite 4304 adhesive, and | |||
| Formlabs equipment: Form 2 | |||
| printer, FormWash and FormCure | |||
| washing and post-curing | |||
| equipment. | The Simplant® Guide is intended | ||
| for use in assisting placement of | |||
| dental implants. | Both the subject Simplant® Digital Guide and | ||
| predicate Simplant® Guide (K170849) are | |||
| intended for use in assisting placement of dental | |||
| implants. However, predicate Simplant® Guide | |||
| (K170849) is fabricated locally by Dentsply | |||
| Sirona and subject Simplant® Digital Guide is | |||
| fabricated locally by the clinician or dental lab. | |||
| Function and | |||
| Principle of | |||
| Operation | Supporting surface: | ||
| teeth and mucosa Function: | |||
| Guidance of instruments | |||
| according to pre-operative | |||
| plan Surgical procedure: | |||
| Sequence of instruments | |||
| according to manufacturer's | |||
| instructions. | Supporting surface: | ||
| teeth, mucosa and bone Function: | |||
| Guidance of instruments | |||
| according to pre-operative | |||
| plan Surgical procedure: | |||
| Sequence of instruments | |||
| according to manufacturer's | |||
| instructions. | The function and principle of operation of the | ||
| subject Simplant® Digital Guide are almost | |||
| identical to the function and principle of | |||
| operation of the predicate Simplant® Guide | |||
| (K170849). The subject Simplant® Digital Guide | |||
| is limited to seating on teeth, mucosa and | |||
| combination thereof. Predicate Simplant® Guide | |||
| (K170849) can also be seated directly on the | |||
| bone. The fabrication process of subject | |||
| Simplant® Digital Guide is not adapted to | |||
| fabrication of bone models, which are needed | |||
| for quality control verification of bone supported | |||
| surgical guides. Therefore, subject Simplant® | |||
| Digital Guide is not intended as a bone | |||
| supported variant. | |||
| Element | Subject Device | ||
| Simplant® Digital Guide | Predicate | ||
| Device | |||
| Simplant® Guide | Similarities and Differences | ||
| Technology | Guide design by Dentsply | ||
| Sirona or by clinician and review | |||
| by Dentsply Sirona. | |||
| Local fabrication by | |||
| stereolithography. | |||
| Print: |
- Software: PreForm
(manufacturer: Formlabs) - Equipment: Form 2
(manufacturer: Formlabs) Wash:
Equipment: Form Wash
(manufacturer: Formlabs) Post-cure:
Equipment: Form Cure
(manufacturer: Formlabs) | Guide design by Dentsply
Sirona or by clinician and review
by Dentsply Sirona.
Internal (Dentsply Sirona)
fabrication by stereolithography. | The design process for the subject Simplant®
Digital Guide and predicate Simplant® Guide
(K170849) are the same.
The technology applied to create the subject
Simplant® Digital Guide is different from
predicate Simplant® Guide (K170849). Both
subject and predicate device are created by
stereolithography, however, the fabrication of
predicate Simplant® Guide (K170849) is
executed centrally by Dentsply Sirona and the
fabrication of subject Simplant® Digital Guide is
performed locally by the clinician or lab utilizing
the Formlabs printer and acrylic resin.
Bench and performance testing is included to
address technological differences between the
subject and predicate device in support of
substantial equivalence. |
| Material | Body:
Acrylic resin: Dental SG
(manufacturer: Formlabs) Metal tube/sleeve:
Titanium alloy Adhesive:
Loctite 4304 | Body:
Acrylic resin Metal tube/sleeve:
Titanium alloy or stainless
steel Adhesive | The material composition of the subject
Simplant® Digital Guide is different than that of
the predicate Simplant® Guide (K170849). While
both are fabricated from acrylic resin in an
additive manufacturing process, a different
specific acrylic resin is used for the subject
device. The material for tubes/sleeves is limited
to titanium alloy and the glue is the same.
Assessment of the biocompatibility of the
subject device is included to address the
material and process differences between the
subject and predicate device in support of
substantial equivalence. |
| Element | Subject Device
Simplant® Digital Guide | Predicate
Device
Simplant® Guide
(K170849) | Similarities and Differences |
| Design and
Features | Body: - Surface following
- Wall thickness: minimum
2.5 mm Metal tube/sleeve:
Dimensions and position
depending on pre-operative
plan | Body: - Surface following
- Wall thickness: minimum
2.5 mm Metal tube/sleeve:
Dimensions and position
depending on pre-operative
plan | The fundamental design parameters and metal
tubes of the subject Simplant® Digital Guide are
identical as compared to predicate Simplant®
Guide (K170849). |
| Sterilization
Method | Sterilization by the user: | Sterilization by the user: | The sterilization method is the same. . |
| Shelf Life | 2 weeks | 2 months | The shelf life of the subject Simplant® Digital
Guide is reduced as compared to predicate
Simplant® Guide (K170849). This difference is
supported by the fact that the local manufacture
of the subject device lends itself to use of the
device within a short time period after fabrication. |
6
7
8
Non-Clinical Performance Data.
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence include data from the following tests:
Bench Testing:
-
. Tube fixation test - push out.
This test is executed to ensure that the subject device withstands typical vertical loads that may be applied during surgery. -
. Tube fixation test - torque.
This test is executed to ensure that the subject device withstands occasional torque loads that may be applied during surgery. -
. Strength test.
This test is executed to ensure that the subject device complies with the international standard related to dental materials, ISO 20795-1:2013-1 Dentistry - Base polymers - Part 1: Denture base polymers. -
Angulation deviation test.
This test is executed to ensure that the subject device is manufactured according to its pre-operative plan regarding the angular position of the quide sleeve. -
. Position deviation test.
This test is executed to ensure that the subject device is manufactured according to its pre-operative plan regarding the spatial position of the quide sleeve. -
. Vertical fit test.
This test is executed to ensure that the subject device is manufactured according to its pre-operative plan regarding the vertical position. As a result of the angulation deviation test, the centrally controlled (by Dentsply Sirona) design process is updated. For the subject device the safety margin between the planned implant and the lingual bone plate is slightly increased.
Development of bench testing to support the assessment of the additive manufacturing process variables was conducted with reference to the December, 2017 Guidance for Industry and Food and Drug Administration Staff: Technical Considerations for Additive Manufactured Medical Devices.
- . The additive manufacturing process workflow was validated considering the critical additive manufacturing process variables that could affect the final product specifications. Considerations for build location, build orientation, print layer thickness, and potential for raw material reuse were made. Strength test, tube fixation (pushout and torque), angulation deviation, position deviation, and vertical fit tests were conducted on samples from at least 3 build runs to confirm that the process variables do not affect the finished device's conformance to its predetermined specifications.
9
Biocompatibility Testing:
Biocompatibility assessment and relevant testing based on the requirements of ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry was performed for the subject Simplant® Digital Guide. It is concluded that the subject Simplant® Digital Guide meets the criteria for biocompatibility according to these standards.
Sterilization Validation:
The updated steam sterilization parameters were validated according to ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices and ISO 17665-2:2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 demonstrating a sterility assurance level (SAL) of 10-9.
Shelf Life Testing:
The shelf life of the subject Simplant® Digital Guide is 2 weeks. To ensure the performance of subject Simplant® Digital through the claimed shelf life, all the performed bench testing on subject device was executed on samples that were sterilized and subjected to real-time aging for 2 weeks.
The results from the non-clinical performance testing, in combination with an updated design process, support substantial equivalence of the subject device Simplant® Digital Guide to the predicate device Simplant® Guide (K170849).
Clinical Performance Data.
No data from human clinical studies has been included to support the substantial equivalence of the Simplant® Digital Guide.
Conclusion Regarding Substantial Equivalence
The subject Simplant® Digital Guide is a patient specific surgical template which is intended for use in assisting placement of dental implants. The Simplant® Digital Guide has identical Indications for Use, exhibits identical fundamental design features and similar principles of operation as the predicate Simplant® Guide cleared under premarket notification K170849. Test data to verify the performance of the Simplant® Digital Guide has been included. The results of this testing, and the comparison with the predicate device, support substantial equivalence.