(244 days)
Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.
The subject devices are part of the Straumann® Dental Implant System, which is an integrated system of endosseous dental implants with corresponding abutments and healing components as well as instruments and prosthetic parts. Straumann® dental implants are solid screw implants with a bone anchorage surface that is large-grit sandblasted and acid-etched. In addition, SLActive® is in a chemically activated state, which is preserved by storage in a saline solution (NaCI). Straumann® dental implants can be used following the extraction or loss of natural teeth to restore chewing function. The prosthetic restorations supported are single crowns, bridges and partial or full dentures, which are connected to the implants using the corresponding abutments.
The BLC and TLC implants features the TorcFit connection and are available in the maximum endosteal outer diameters ø 3.3 mm, ø 3.75 mm, ø 5.5 mm and Ø 6.5 mm.
The BLC implants are available with the following length options:
- L 8 mm to L 18 mm for the maximum endosteal outer diameter Ø 3.3 mm.
- L 6 mm to L 18 mm for diameters Ø 3.75 mm and Ø 4.5 mm
- L 6 mm to L 16 mm for diameter Ø 5.5 mm
- L 6 mm to 14 mm for diameter Ø 6.5 mm.
The subject BLC implants are presented with RB (Reqular Base) and WB (Wide Base) prosthetic platform.
The TLC implants are available with the following length options:
- L 8 mm to L 18 mm for the maximum endosteal outer diameter Ø 3.3 mm,
- L 6 mm to L 18 mm for diameters ø 3.75 mm and ø 4.5 mm
- L 6 mm to L 12 mm for diameter Ø 5.5 mm
- L 6 mm to 10 mm for diameter Ø 6.5 mm.
The subject TLC implants are presented with the NT (Narrow TorcFit) RT (Regular TorcFit) WT (Wide TorcFit) prosthetic platform. The implant neck is available either as Standard (2.8 mm height) or Standard Plus (1.8 mm height) option.
The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria in the context of an AI/ML medical device. The document is an FDA 510(k) summary for Straumann® BLC and TLC Implants, which are endosseous dental implants, not an AI/ML device.
Therefore, I cannot provide the requested information.
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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
9/14/23
Institut Straumann AG % Jennifer Jackson Sr. Director, Regulatory Affairs and Ouality StraumannUSA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K230108
Trade/Device Name: Straumann® BLC and TLC Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: August 10, 2023 Received: August 11, 2023
Dear Jennifer Jackson:
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.
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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) 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.
Sherrill Lathrop Blitzer
for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number:
Device Name
Straumann® BLC and TLC Implants
Indications for Use (Describe)
Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.
Type of Use (Select one or both, as applicable) 図Prescription Use (Part 21 CFR 801 Subpart D)
□Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Straumann® BLC and TLC Implants
510(k) Summary
510(k) Summary – K230108 5
5.1 Submitter's Contact Information
| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG)60 Minuteman RoadAndover, MA 01810Registration No.: 1222315 Owner/Operator No.: 9005052On the behalf of:Institut Straumann AGPeter Merian-Weg 124052 Basel, Switzerland |
|---|---|
| Contact Person: | Jennifer M. Jackson, MS, RACSr. Director, Regulatory Affairs and QualityPhone Number: +1-978-747-2509Fax Number: +1-978-747-0023 |
| Prepared By &Alternate Contact: | Corinne ArimateaRegulatory Affairs and Compliance ManagerInstitut Straumann AGPhone number: +41 61 965 1217 |
| Date of Submission: | September 14, 2023 |
5.2 Name of the Device
| Trade Names: | Straumann® BLC and TLC Implants |
|---|---|
| Common Name: | Endosseous Dental Implant |
| Classification Name: | Endosseous Dental Implant |
| Regulation Number: | §872.3640 |
| Device Classification: | II |
| Product Code(s): | DZE |
| Classification Panel: | Dental |
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Straumann® BLC and TLC Implants
510(k) Summary
Predicate Device(s) 5.3
Primary Predicate:
-
K150938 Straumann® Dental Implant System Roxolid® SLA Implants .
Reference Devices: -
K173961 Straumann BLX Implant System .
-
K210855 Straumann BLX Implant System .
-
K212533 BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants .
-
K200586 Straumann TLX Implant System .
-
K153758 Straumann Bone Level Tapered Implants .
Device Description 5.4
The subject devices are part of the Straumann® Dental Implant System, which is an integrated system of endosseous dental implants with corresponding abutments and healing components as well as instruments and prosthetic parts. Straumann® dental implants are solid screw implants with a bone anchorage surface that is large-grit sandblasted and acid-etched. In addition, SLActive® is in a chemically activated state, which is preserved by storage in a saline solution (NaCI). Straumann® dental implants can be used following the extraction or loss of natural teeth to restore chewing function. The prosthetic restorations supported are single crowns, bridges and partial or full dentures, which are connected to the implants using the corresponding abutments.
The BLC and TLC implants features the TorcFit connection and are available in the maximum endosteal outer diameters ø 3.3 mm, ø 3.75 mm, ø 5.5 mm and Ø 6.5 mm.
The BLC implants are available with the following length options:
- L 8 mm to L 18 mm for the maximum endosteal outer diameter Ø 3.3 mm.
- L 6 mm to L 18 mm for diameters Ø 3.75 mm and Ø 4.5 mm
- L 6 mm to L 16 mm for diameter Ø 5.5 mm
- L 6 mm to 14 mm for diameter Ø 6.5 mm.
The subject BLC implants are presented with RB (Reqular Base) and WB (Wide Base) prosthetic platform.
A summary of the diameter/length implant body combinations is given in Table 1.
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Straumann® BLC and TLC Implants
| Implant Diameter | ø 3.3mm | ø 3.75mm | ø 4.5mm | ø 5.5mm | ø 6.5mm |
|---|---|---|---|---|---|
| Implant Length | - | 6 mm | 6 mm | 6 mm | 6 mm |
| 8 mm | 8 mm | 8 mm | 8 mm | ||
| 10 mm | 10 mm | 10 mm | 10 mm | ||
| 12 mm | 12 mm | 12 mm | 12 mm | ||
| 14 mm | 14 mm | 14 mm | 14 mm | ||
| 16 mm | 16 mm | 16 mm | 16 mm | ||
| 18 mm | 18 mm | 18 mm | - | ||
| Prosthetic platforms | RB | RB | WB | WB | WB |
510(k) Summary
Table 1 – Overview of diameter/length implant body combinations for BLC implants
The TLC implants are available with the following length options:
- L 8 mm to L 18 mm for the maximum endosteal outer diameter Ø 3.3 mm,
- L 6 mm to L 18 mm for diameters ø 3.75 mm and ø 4.5 mm
- L 6 mm to L 12 mm for diameter Ø 5.5 mm
- L 6 mm to 10 mm for diameter Ø 6.5 mm.
The subject TLC implants are presented with the NT (Narrow TorcFit) RT (Regular TorcFit) WT (Wide TorcFit) prosthetic platform. The implant neck is available either as Standard (2.8 mm height) or Standard Plus (1.8 mm height) option.
A summary of the diameter/length implant body combinations is given in Table 2.
| Implant Diameter | ø 3.3mm | ø 3.75mm | ø 4.5mm | ø 5.5mm | ø 6.5mm |
|---|---|---|---|---|---|
| Implant Length | - | 6 mm | 6 mm | 6 mm | 6 mm |
| 8 mm | 8 mm | 8 mm | 8 mm | 8 mm | |
| 10 mm | 10 mm | 10 mm | 10 mm | 10 mm | |
| 12 mm | 12 mm | 12 mm | 12 mm | - | |
| 14 mm | 14 mm | 14 mm | - | - | |
| 16 mm | 16 mm | 16 mm | - | - | |
| 18 mm | 18 mm | 18 mm | - | - | |
| Prosthetic platforms | NT / RT | NT / RT | RT / WT | WT | WT |
Table 2 – Overview of diameter/length implant body combinations for TLC implants
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Straumann® BLC and TLC Implants
510(k) Summary
Intended Use 5.5
Straumann® dental implants and abutments are intended for oral implantation to provide a support structure for connected prosthetic devices.
5.6 Indications for Use
Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.
Technological Characteristics 5.7 -
The technological characteristics of the subject devices are compared to the primary predicate and reference devices in the following tables:
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Straumann® BLC and TLC Implants
510(k) Summary
| FEATURE | PROPOSEDDEVICE | PRIMARYPREDICATEDEVICE | REFERENCEDEVICE | REFERENCEDEVICE | REFERENCEDEVICE | REFERENCEDEVICE | PROPOSEDDEVICE | PRIMARYPREDICATE DEVICE | REFERENCEDEVICE | REFERENCE DEVICE | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| K Number | K230108 | K150938 | K173961 | K210855 | K212533 | K153758 | K Number | K230108 | K150938 | K200586 | K153758 |
| Indicationsfor Use | Straumann®dental implantsare indicatedfor thefunctional andesthetic oralrehabilitation ofthe upper orlower jaw ofedentulous orpartiallyedentulouspatients. Theycan be used forimmediate,early or lateimplantationfollowing theextraction orloss of naturalteeth. Theimplants can beplaced withimmediatefunction forsingle-toothand/or multiple-toothrestorationswhen goodprimary stabilityis achieved andwith appropriateocclusal loadingto restorechewingfunction. | Straumann®dental implantsare indicatedfor oralendostealimplantation inthe upper andlower jaw andfor thefunctional andesthetic oralrehabilitation ofedentulous andpartially dentatepatients.Straumanndental implantscan also beused forimmediate orearlyimplantationfollowingextraction orloss of naturalteeth. Implantscan be placedwith immediatefunction onsingle-toothand/or multipletoothapplicationswhen goodprimary stabilityis achieved andwith appropriateocclusalloading, torestore chewingfunction. Theprostheticrestorationsused are singlecrowns, bridgesand partial orfull dentures,which areconnected tothe implants bythecorrespondingelements(abutments). | Straumann®BLX Implantsare suitable forendostealimplantation inthe upper andlower jaw andfor thefunctional andesthetic oralrehabilitation ofedentulous andpartiallyedentulouspatients. BLXImplants canbe placed withimmediatefunction onsingle-toothapplicationswhen goodprimary stabilityis achieved andwithappropriateocclusalloading torestorechewingfunction. Theprostheticrestorations areconnected tothe implantsthrough thecorrespondingabutmentcomponents. | Straumann BLXImplants aresuitable forendostealimplantation inthe upper andlower jaw andfor thefunctional andesthetic oralrehabilitation ofedentulous andpartiallyedentulouspatients. BLXimplants canbe placed withimmediatefunction onsingle-tooth andmulti-unitrestorationswhen goodprimary stabilityis achieved andwith appropriateocclusalloading, torestore chewingfunction. Theprostheticrestorationsused areconnected tothe implantsthrough thecorrespondingabutmentcomponents. | Straumann®dental implantsare indicatedfor thefunctional andesthetic oralrehabilitation ofthe upper orlower jaw ofedentulous orpartiallyedentulouspatients. Theycan be used forimmediate,early or lateimplantationfollowing theextraction orloss of naturalteeth. Theimplants can beplaced withimmediatefunction forsingle-toothand/or multiple-toothrestorationswhen goodprimary stabilityis achieved andwith appropriateocclusal loadingto restorechewingfunction. | Straumann®dental implantsare indicatedfor oralendostealimplantation inthe upper andlower jaw andfor thefunctional andesthetic oralrehabilitation ofedentulous andpartially dentatepatients.Straumanndental implantscan also beused forimmediate orearlyimplantationfollowingextraction orloss of naturalteeth. Implantscan be placedwith immediatefunction onsingle-toothand/or multipletoothapplicationswhen goodprimary stabilityprimarypredicate isachieved andwith appropriateocclusalloading, torestore chewingfunction. Theprostheticrestorationsused are singlecrowns, bridgesand partial orfull dentures,which areconnected tothe implants bythecorrespondingelements(abutments). | Indicationsfor Use | Straumann® dentalimplants are indicatedfor the functional andesthetic oralrehabilitation of theupper or lower jaw ofedentulous or partiallyedentulous patients.They can be used forimmediate, early or lateimplantation followingthe extraction or loss ofnatural teeth. Theimplants can be placedwith immediate functionfor single-tooth and/ormultiple-toothrestorations when goodprimary stability isachieved and withappropriate occlusalloading to restorechewing function. | Straumann® dentalimplants are indicated fororal endostealimplantation in the upperand lower jaw and for thefunctional and estheticoral rehabilitation ofedentulous and partiallydentate patients.Straumann dentalimplants can also beused for immediate orearly implantationfollowing extraction orloss of natural teeth.Implants can be placedwith immediate functionon single-tooth and/ormultiple tooth applicationswhen good primarystability is achieved andwith appropriate occlusalloading, to restorechewing function. Theprosthetic restorationsused are single crowns,bridges and partial or fulldentures, which areconnected to the implantsby the correspondingelements (abutments). | Straumann TLX Implantsare suitable for endostealimplantation in the upperand lower jaws and forthe functional andesthetic oral rehabilitationof edentulous andpartially edentulouspatients. TLX Implantscan be placed withimmediate function onsingle-tooth and multi-unit restorations whengood primary stability isachieved and withappropriate occlusalloading to restorechewing function. Theprosthetic restorationsare connected to theimplants through thecorresponding abutmentcomponents. | Straumann® dentalimplants are indicated fororal endostealimplantation in the upperand lower jaw and for thefunctional and estheticoral rehabilitation ofedentulous and partiallydentate patients.Straumann dentalimplants can also beused for immediate orearly implantationfollowing extraction orloss of natural teeth.Implants can be placedwith immediate functionon single-tooth and/ormultiple tooth applicationswhen good primarystability primary predicateis achieved and withappropriate occlusalloading, to restorechewing function. Theprosthetic restorationsused are single crowns,bridges and partial or fulldentures, which areconnected to the implantsby the correspondingelements (abutments). |
| FEATURE | PROPOSEDDEVICE | PRIMARYPREDICATEDEVICE | REFERENCEDEVICE | REFERENCEDEVICE | REFERENCEDEVICE | REFERENCEDEVICE | Material | Titanium-13 Zirconiumalloy (Roxolid®) | Titanium-13 Zirconiumalloy(Roxolid®) | Titanium-13 Zirconiumalloy (Roxolid®) | Titanium-13 Zirconiumalloy (Roxolid®) |
| K Number | K230108 | K150938 | K173961 | K210855 | K212533 | K153758 | SurfaceTreatment | Hydrophilic SLActive®and SLA® | Hydrophilic SLA® | Hydrophilic SLActive® | Hydrophilic SLActive® |
| Material | Titanium-13Zirconium alloy(Roxolid®) | Titanium-13Zirconium alloy(Roxolid®) | Titanium-13Zirconium alloy(Roxolid®) | Titanium-13Zirconium alloy(Roxolid®) | Titanium-13Zirconium alloy(Roxolid®) | Titanium-13Zirconium alloy(Roxolid®) | Implant toAbutmentConnection | TorcFit(with conical fitting) | Narrow CrossFit (NC)Regular CrossFit (RC)Narrow Neck CrossFit(NNC)Regular Neck (RN)Wide Neck (WN) | TorcFit(with conical fitting) | Narrow CrossFit® (NC)Regular CrossFit® (RC) |
| SurfaceTreatment | HydrophilicSLActive® andSLA® | HydrophilicSLA® | HydrophilicSLActive® | HydrophilicSLActive® andSLA® | HydrophilicSLActive® andSLA® | HydrophilicSLActive® | ImplantDiameter | $Ø 3.3, 3.75, 4.5, 5.5, 6.5 mm$ | $Ø 3.3, 4.1, 4.8 mm$ | $Ø 3.75, 4.5, 5.5, 6.5 mm$ | $Ø 3.3, 4.1, 4.8 mm$ |
| Implant toAbutmentConnection | TorcFit(with conicalfitting) | NarrowCrossFit (NC)RegularCrossFit (RC)Narrow NeckCrossFit (NNC)Regular Neck(RN)Wide Neck(WN) | TorcFit(with conicalfitting) | TorcFit(with conicalfitting) | TorcFit(with conicalfitting) | NarrowCrossFit® (NC)RegularCrossFit® (RC) | ImplantLength | $Ø 3.3: 8, 10, 12, 14, 16,18 mm$$Ø 3.75 and 4.5:6, 8, 10, 12, 14, 16,18 mm$$Ø 5.5: 6, 8, 10, 12 mm$$Ø 6.5: 6, 8, 10 mm$ | $6, 8, 10, 12, 14, 16 mm$ | $Ø 3.75, 4.0, 4.5, 5.0 mm:6, 8, 10, 12, 14, 16,18 mm$$Ø 5.5 and 6.5 mm:6, 8, 10, 12 mm$ | $18 mm$ |
| ImplantDiameter | Ø 3.3, 3.75, 4.5,5.5, 6.5 mm | Ø 3.3, 4.1, 4.8mm | Ø 4.5, 5.5,6.5 mm | Ø 3.75 and 4.0mm | Ø 5.0, 5.5, 6.5mm | Ø 3.3, 4.1, 4.8mm | ImplantDesign | Apically tapered TissueLevel implant | Parallel wall andApically tapered BoneLevel implant | Fully tapered TissueLevel implant | Apically tapered BoneLevel implant |
| ImplantLength | Ø 3.3: 8, 10, 12,14, 16, 18 mmØ 3.75 and 4.5:6, 8, 10, 12, 14,16, 18 mmØ 5.5: 6, 8, 10,12, 14, 16 mmØ 6.5: 6, 8, 10,12, 14 mm | 8, 10, 12, 14and 16 mm | Ø 4.5: 6 to 18mmØ 5.5 and 6.5:6 to 12 mm | 6 mm | Ø 5.0: 18 mmØ 5.5 and 6.5:14 and 16 mm | 18 mm | |||||
| ImplantDesign | Apically taperedBone Levelimplant | Parallel wallandApically taperedBone Levelimplant (BLT) | Fully taperedBone Levelimplant | Fully taperedBone Levelimplant | Fully taperedBone Levelimplant | Apically taperedBone Levelimplant (BLT) | |||||
| ThreadPitch | 0.8, 0.9, 1 and1.15 mm | 0.8 and 1.25mm | 2.0 to 2.8 mm | 1.7 to 1.8 mm | 2.5 to 3.1 mm | 0.8 mm | |||||
| SterilizationMethod | Irradiation | Irradiation | Irradiation | Irradiation | Irradiation | Irradiation |
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Straumann® BLC and TLC Implants
510(k) Summary
Table 3 – Comparison of subject device versus primary predicate and reference device –
BLC implant
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Straumann® BLC and TLC Implants
510(k) Summary
{10}------------------------------------------------
Straumann® BLC and TLC Implants
| PROPOSEDDEVICE | PRIMARYPREDICATE DEVICE | REFERENCEDEVICE | REFERENCE DEVICE | |
|---|---|---|---|---|
| K Number | K230108 | K150938 | K200586 | K153758 |
| Implantneck | Tulip shape | Tulip shapen/a (bone level) | Tulip shape | n/a (bone level) |
| Prostheticplatform | NT, RT and WT | NC, RC, NNC, RN, andWN | NT, RT and WT | NC and RC |
| ThreadPitch | 0.8, 0.9, 1 and 1.15 mm | 0.8 and 1.25 mm | 1.7, 2.0, 2.1, 2.2, 2.5,2.6, and 2.8 mm | 0.8 mm |
| SterilizationMethod | Irradiation | Irradiation | Irradiation | Irradiation |
510(k) Summary
Table 4 - Comparison of subject device versus primary predicate and reference device - TLC implant
The Indications for Use of the primary predicate and subject devices are identical. Both devices are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients, with identical use. The Indications for Use of the primary predicate device includes details of prosthetic restoration, whereas for the subject devices, those details are provided in the Product Description section.
The subject devices have identical or equivalent technological characteristics compared to the primary predicate and reference devices. The material, surface treatment, sterilization method, and implant characteristics (length, diameter & connection) are identical to the primary predicate and reference devices. The device performance demonstrates substantial equivalence between subject devices and primary predicate/reference devices.
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Traditional 510(k) Submission Straumann® BLC and TLC Implants
Appendix 5-9
5.8 Performance Testing
Sterilization Validation and Shelf-life
The subject devices are provided sterile via gamma irradiation at a dose of 25 kGy and will be sterilized after final packaging. The sterilization process for the subject devices as recommended in the labeling was validated to a sterility assurance level (SAL) of 10° in accordance with ISO 11137-1:2006, "Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, 2006-04-05". The validation method used was the over kill bioburden (or VDmax25) method in accordance with ISO 11137- 2:2013, "Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose". There are no changes to the sterilization procedures or processes from those of the Straumann primary predicate devices (K150938), the subject devices do not represent a higher challenge to the sterilization process in comparison to the validated worst-case product and validated irradiation sterilization process.
The packaging of the subject device is equivalent to the packaging of the primary predicate and reference device. The shelf life for devices provided sterile is 5 years.
The devices will not be marketed as non-pyrogenic. Pyrogenicity information provided is based on FDA Guidance on "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile, issued on 21 January 2016." The method used to determine the device meets pyrogen limit specifications is LAL Endotoxin Analysis with testing limit of 20 EU/device, based on a blood contacting and implanted device.
Biocompatibility Testing
Biological assessment has been performed according to ISO 10993-1 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and to the FDA Guidance document "Use of International Standard ISO 10993- 1, 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff, Document issued on: June 16, 2016" for each of the subject devices.
The subject devices are equivalent in material, surface, manufacturing processes, sterilization process, body contact and contact duration to the reference device K210855 therefore, no new issues regarding biocompatibility were raised.
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Straumann® BLC and TLC Implants
Appendix 5-10
Electromagnetic Compatibility
There are no significant changes to the materials and dimensions from the currently marketed predicate devices. Therefore, no new issues of electromagnetic compatibility are raised for the subject devices and they can be considered MR Conditional.
The subject implants have obtained the status of MR Conditional per K180540. The MR Conditional tests were conducted according to FDA's Guidance "Testing and Labeling Medical Devices for Safety in Magnetic Resonance (MR) Environment".
Performance Testing – Bench
Dynamic fatigue testing was conducted according to the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801 "Dentistry — Implants — Dynamic loading test for endosseous dental implants" and demonstrated the subject devices are equivalent to the primary predicate and reference devices. The test was conducted in saline (2 Hz and 37°C) at 2 million cycles covering permanent restoration of the implant without failure.
Insertion tests were performed for the subject implants and it could be proven that there is an adequate insertion torque in different bone classes when the implant is inserted according to the surgical procedure.
A comparison of the bone-to-implant contact (BIC) and pull-out force between the subject implants and previously cleared devices (K150938) was performed.
-
As part of the BIC evaluation, the nominal endosseous surface area of the subject devices was calculated and then compared to the contact surface area of the reference devices. The analysis concludes that the acceptance criterion is met; the subject devices have a larger endosseous surface area, and therefore, more area of bone-to-implant contact compared to the corresponding reference device.
-
To determine the pull-out force, the implants were inserted in bone substitute material and then pulled-out while the resistance was measured. The analysis concludes that the acceptance criterion is met; the subject devices have a higher pull-out force compared to the corresponding reference device.
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Straumann® BLC and TLC Implants
Appendix 5-11
The subject devices were analyzed using scanning electron microscopy and light microscopy to investigate the apical end of the implant body after removal from the packaging. All the inspected implants showed a uniform breaking surface, with no residual metal fragments at the broken tip area.
The subject device surface treatments are identical to the surface treatments of the primary predicate and reference devices cleared under K150938. K173961. K210855. K200586 and K153758. The SLA® surface treatment is a sand-blasted, large grit, acid etched surface. The SLActive® surface treatment is a sand-blasted, large grit, acid etched, chemically active and hydrophilic surface. The surface is routinely tested by roughness measurement or scanning electron microscopy.
Conclusion
The documentation submitted in this premarket notification demonstrates the subject devices are substantially equivalent to the primary predicate and reference devices.
§ 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.