(90 days)
No
The summary describes a dental implant abutment system and its components, focusing on materials, manufacturing processes (CAD/CAM, milling), and mechanical testing. There is no mention of AI or ML in the intended use, device description, or performance studies. The software mentioned (Straumann CARES Visual, Dental Wings) is for CAD/CAM design, not AI/ML analysis.
No
The device, Straumann® Variobase® prosthetic components, is described as an aid in prosthetic rehabilitations for dental implants, and its function is to serve as a base for crowns, not to directly treat or cure a disease or condition.
No
Explanation: The device described, Straumann® Variobase® prosthetic components, is intended for use in prosthetic rehabilitations by connecting to dental implants for various types of restorations (crowns, copings). It is a structural component used to aid in the physical placement and support of dental prostheses. There is no mention of it collecting or analyzing data from the patient's body for diagnostic purposes within the provided text. Its function is restorative, not diagnostic.
No
The device description clearly outlines physical components (titanium bases, basal screws, prosthetic restorations) and manufacturing processes (milling), indicating it is a hardware device with associated software for design.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "prosthetic rehabilitations" and is "directly or indirectly connected to the endosseous dental implant." This describes a physical component used in a surgical and restorative procedure within the body.
- Device Description: The description details a "two-piece abutment" made of titanium alloy, designed to be screwed onto a dental implant. This is a mechanical device for supporting a dental restoration.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. The device itself is the treatment component.
- Performance Studies: The performance studies described are "Dynamic fatique tests" on the implant-abutment system, which are mechanical tests, not diagnostic performance studies.
Therefore, the Straumann® Variobase® prosthetic components are a medical device used in dental surgery and prosthetics, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Straumann® Variobase® prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. The prosthetic restoration (crowns) can be cemented onto the Straumann® Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase. They must be placed out of occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed copings and/or crowns for use with the Strauman® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.
Product codes
NHA
Device Description
BLX Variobase abutments are two-piece abutments composed of the following components:
- Variobase™ Abutment (Ti-base)
- Prosthetic restoration (coping or crown)
- Basal Screw
The BLX Variobase abutments are titanium bases to be used as the lower part of two-piece abutments. The upper part of the two-piece abutment is a CAD/CAM designed and manufactured restoration. The planning and milling of the customized restoration must be made using the validated Straumann CARES Visual, Dental Wings software using the Straumann CARES Visual Plug-In. All digitally designed copings and/or crowns for use on the Variobase abutments are intended to be manufactured at a validated milling center.
The BLX Variobase Abutments are manufactured from TAN (titanium-aluminum-niobium alloy) and are available in different gingiva heights and diameters. The abutments are delivered with the corresponding basal screw.
The prosthetic restoration (copings/crowns) can be cemented onto the Variobase abutment and then the set is screwed on the implant using the basal screw.
The BLX Variobase Abutments will be marketed as a stand-alone component or through the CARES® X-Stream™ workflow (prosthetic restoration designed and manufactured through CARES® Visual/validated Straumann milling and then shipped together with the Straumann® BLX Variobase® Abutment and basal screw in the same shipment).
The BLX Variobase abutments are cleared under K173961.
The purpose of this premarket notification is to extend the Straumann BLX Implant System portfolio with additional materials for customized restorations (upper part of the two-piece abutment) for use with the BLX Variobase abutments (lower part of the twopiece abutment).
Prosthetic Restoration Design and Materials
The following is an overview of the possible coping/crown materials:
- Digital materials:
The manufacturing of the coping and/or crown should follow the standard procedure according to the material manufacturer's instructions for use. The design of the digital coping and/or crown should follow the standard procedure according to the material manufacturer's instructions for use and Straumann's instructions for use.
Basal screws are used to fix the BLX Variobase Abutments to the dental implant, and can be also used during lab procedures to fix lab prosthetic parts on implant analogs. There is one basal screw for the RB platform and one for the WB platform. They have identical designs and differ only in color-coding (violet for RB and brown for WB) to ease the handling. They are provided along the abutments but they are also provided as standalone (replacement) screws. The BLX basal screws are manufactured from TAN.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing:
Sterilization and Shelf Life:
The sterilization process for the BLX Variobase Abutments as recommended in the labeling was validated according to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015" and according to ISO 17655-1, Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices."
Biocompatibility:
Biocompatibility was evaluated according to ISO 10993-1:2009 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and the biocompatibility evaluation flow chart according 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. No new issues of biocompatibility are raised for the subject devices and therefore, no additional biocompatibility testing was required.
Performance Testing Bench:
Dynamic fatique tests for the implant-abutment system were 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 according to ISO 14801, "Dentistry -- Implants -- Dynamic loading test for endosseous dental implants". The test results demonstrated the Straumann® BLX Implant/Variobase final abutment system is equivalent to the predicate and reference devices. The test environment was 0.9% NaCl at 37°.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)
0
Indications for Use
510(k) Number (if known) K190082
Device Name Straumann® BLX Variobase Abutment
Indications for Use (Describe)
Straumann® Variobase® prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. The prosthetic restoration (crowns) can be cemented onto the Straumann® Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase. They must be placed out of occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed copings and/or crowns for use with the Strauman® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 |
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Subpart C)
1
Straumann®BLX Variobase Abutment
510(k) Summary
510(k) Summary 5
Submitter's Contact Information 5.1
Straumann USA, LLC (on behalf of Institut Straumann AG)
60 Minuteman Road
Andover, MA 01810
| Phone Number: | 1-978-747-2509 |
|---|---|
| --------------- | ---------------- |
Fax Number: 1-978-747-0023
Contact Person: Jennifer M. Jackson, MS
Prepared by: Viviana Horhoiu
Date of Submission: April 16, 2019
5.2 Name of the Device
| Trade Names: | Straumann® BLX Variobase Abutment |
|---|---|
| Common Name: | Endosseous Dental Implant Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Classification: | Class II |
| Product Codes: | NHA |
5.3 Predicate Device(s)
Primary Predicate Device:
-
. K173961 – Straumann BLX Implant System
Reference Devices: -
K170356 Straumann Variobase Abutments .
-
K162890 Small Diameter Implant (SDI) ●
-
. K142890 – Straumann® Variobase Abutments
2
Straumann®BLX Variobase Abutment
510(k) Summary
5.4 Device Description
BLX Variobase abutments are two-piece abutments composed of the following components:
- . Variobase™ Abutment (Ti-base)
- Prosthetic restoration (coping or crown) .
- . Basal Screw
The BLX Variobase abutments are titanium bases to be used as the lower part of two-piece abutments. The upper part of the two-piece abutment is a CAD/CAM designed and manufactured restoration. The planning and milling of the customized restoration must be made using the validated Straumann CARES Visual, Dental Wings software using the Straumann CARES Visual Plug-In. All digitally designed copings and/or crowns for use on the Variobase abutments are intended to be manufactured at a validated milling center.
The BLX Variobase Abutments are manufactured from TAN (titanium-aluminum-niobium alloy) and are available in different gingiva heights and diameters. The abutments are delivered with the corresponding basal screw.
The prosthetic restoration (copings/crowns) can be cemented onto the Variobase abutment and then the set is screwed on the implant using the basal screw.
The BLX Variobase Abutments will be marketed as a stand-alone component or through the CARES® X-Stream™ workflow (prosthetic restoration designed and manufactured through CARES® Visual/validated Straumann milling and then shipped together with the Straumann® BLX Variobase® Abutment and basal screw in the same shipment).
The BLX Variobase abutments are cleared under K173961.
The purpose of this premarket notification is to extend the Straumann BLX Implant System portfolio with additional materials for customized restorations (upper part of the two-piece abutment) for use with the BLX Variobase abutments (lower part of the twopiece abutment).
Prosthetic Restoration Design and Materials
The following is an overview of the possible coping/crown materials:
3
Straumann® BLX Variobase Abutment
510(k) Summary
- Digital materials: .
The manufacturing of the coping and/or crown should follow the standard procedure according to the material manufacturer's instructions for use. The design of the digital coping and/or crown should follow the standard procedure according to the material manufacturer's instructions for use and Straumann's instructions for use.
Basal screws are used to fix the BLX Variobase Abutments to the dental implant, and can be also used during lab procedures to fix lab prosthetic parts on implant analogs. There is one basal screw for the RB platform and one for the WB platform. They have identical designs and differ only in color-coding (violet for RB and brown for WB) to ease the handling. They are provided along the abutments but they are also provided as standalone (replacement) screws. The BLX basal screws are manufactured from TAN.
5.5 Indications for Use
Straumann® Variobase® prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. The prosthetic restoration (crowns) can be cemented onto the Straumann® Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase. They must be placed out of occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.
Technological Characteristics 5.6
The technological characteristics of the subject devices are compared to the primary predicate and reference devices in Table 1.
4
Straumann® BLX Variobase Abutment
510(k) Summary
| SUBJECT DEVICE | PRIMARY PREDICATE | REFERENCE DEVICES | |||
|---|---|---|---|---|---|
| FEATURE | Straumann BLX | ||||
| Variobase Abutment | K173961 | ||||
| Straumann BLX | |||||
| Implant System | K170356 | ||||
| Straumann Variobase | |||||
| Abutments | K162890 | ||||
| Small Diameter Implant | |||||
| (SDI) | K142890 | ||||
| Straumann® Variobase | |||||
| Abutments | |||||
| Indications for | |||||
| Use | Straumann® Variobase® | ||||
| prosthetic components | |||||
| directly or indirectly | |||||
| connected to the | |||||
| endosseous dental implant | |||||
| are intended for use as an | |||||
| aid in prosthetic | |||||
| rehabilitations. The | |||||
| prosthetic restoration | |||||
| (crowns) can be cemented | |||||
| onto the Straumann® | |||||
| Variobase® prosthetic | |||||
| components. A temporary | |||||
| restoration can be used prior | |||||
| to the insertion of the final | |||||
| components to maintain, | |||||
| stabilize and shape the soft | |||||
| tissue during the healing | |||||
| phase; they must be placed | |||||
| out of occlusion. Final | |||||
| abutments and restorations | |||||
| may be placed into | |||||
| occlusion when the implant | |||||
| is fully osseointegrated. All | |||||
| digitally designed copings | |||||
| and/or crowns for use with | |||||
| the Straumann® Variobase® | |||||
| Abutment system are | |||||
| intended to be sent to | |||||
| Straumann for manufacture | |||||
| at a validated milling center. | Straumann® Variobase® | ||||
| prosthetic components | |||||
| directly or indirectly | |||||
| connected to the | |||||
| endosseous dental implant | |||||
| are intended for use as an | |||||
| aid in prosthetic | |||||
| rehabilitations. The | |||||
| prosthetic restoration | |||||
| (crowns) can be cemented | |||||
| onto the Straumann® | |||||
| Variobase® prosthetic | |||||
| components. A temporary | |||||
| restoration can be used prior | |||||
| to the insertion of the final | |||||
| components to maintain, | |||||
| stabilize and shape the soft | |||||
| tissue during the healing | |||||
| phase; they must be placed | |||||
| out of occlusion. Final | |||||
| abutments and restorations | |||||
| may be placed into | |||||
| occlusion when the implant | |||||
| is fully osseointegrated. All | |||||
| digitally designed copings | |||||
| and/or crowns for use with | |||||
| the Straumann® Variobase® | |||||
| Abutment system are | |||||
| intended to be sent to | |||||
| Straumann for manufacture | |||||
| at a validated milling center. | The Straumann® Variobase® | ||||
| Abutment is a titanium base | |||||
| placed onto Straumann | |||||
| dental implants to provide | |||||
| support for customized | |||||
| prosthetic restorations. | |||||
| Straumann® Variobase® | |||||
| Abutments are indicated for | |||||
| screw-retained single tooth | |||||
| or cement-retained single | |||||
| tooth and bridge | |||||
| restorations. All digitally | |||||
| designed copings and/or | |||||
| crowns for use with the | |||||
| Straumann® Variobase® | |||||
| Abutment system are | |||||
| intended to be sent to | |||||
| Straumann for manufacture | |||||
| at a validated milling center. | Straumann® SC Variobase® | ||||
| abutments are indicated for | |||||
| use as an aid in prosthetic | |||||
| rehabilitations. The | |||||
| prosthetic restoration can be | |||||
| cemented on the | |||||
| Straumann® SC Variobase® | |||||
| prosthetic components. A | |||||
| temporary restoration can | |||||
| be used prior to the insertion | |||||
| of the final components to | |||||
| maintain, stabilize and form | |||||
| the soft tissue during the | |||||
| healing phase. Final | |||||
| abutments and restorations | |||||
| may be placed into | |||||
| occlusion when the implant | |||||
| is fully osseointegrated. All | |||||
| digitally designed copings | |||||
| and/or crowns for use with | |||||
| the Straumann® Variobase® | |||||
| Abutment system are | |||||
| intended to be sent to | |||||
| Straumann for manufacture | |||||
| at a validated milling center. | The Straumann® Variobase® | ||||
| Abutment is a titanium base | |||||
| placed onto Straumann | |||||
| dental implants to provide | |||||
| support for customized | |||||
| prosthetic restorations. | |||||
| Straumann® Variobase® | |||||
| Abutments are indicated for | |||||
| screw-retained single tooth | |||||
| or cement-retained single | |||||
| tooth and bridge | |||||
| restorations. All digitally | |||||
| designed copings and/or | |||||
| crowns for use with the | |||||
| Straumann® Variobase® | |||||
| Abutment system are | |||||
| intended to be sent to | |||||
| Straumann for manufacture | |||||
| at a validated milling center. | |||||
| Material | Ti-6Al-7Nb | Ti-6Al-7Nb | Ti-6Al-7Nb | Ti-6Al-7Nb | Ti-6Al-7Nb |
| Implant to | |||||
| Abutment | |||||
| Connection | BLX | ||||
| (with conical fitting) | BLX | ||||
| (with conical fitting) | CrossFit® | Small CrossFit® (SC) | CrossFit® | ||
| synOcta® (RN/WN) | |||||
| Prosthetic | |||||
| Platform | |||||
| Diameter | Ø 3.8 to 5.5 mm | Ø 3.8 to 5.5 mm | Ø 3.9 and 7.0 mm | Ø 3.3/4.3 mm | |
| (minor/major oval | |||||
| dimension) | Ø 3.9 – 7.0 mm | ||||
| SUBJECT DEVICE | PRIMARY PREDICATE | REFERENCE DEVICES | |||
| FEATURE | Straumann BLX | ||||
| Variobase Abutment | K173961 | ||||
| Straumann BLX | |||||
| Implant System | K170356 | ||||
| Straumann Variobase | |||||
| Abutments | K162890 | ||||
| Small Diameter Implant | |||||
| (SDI) | K142890 | ||||
| Straumann® Variobase | |||||
| Abutments | |||||
| Gingival Heights | 0.75 - 3.5 mm | 0.75 — 2.5 mm | 1.0 - 3.0 mm | 1.0 - 3.0 mm | 1.0 - 3.0 mm |
| Chimney | |||||
| Heights | 5.5 mm | ||||
| (can be reduced) | 5.5 mm | ||||
| (can be reduced) | 3.5 - 4.5 mm | 6.7 – 8.7 mm | |||
| (overall height) | 3.5 - 4.5 mm | ||||
| Design Workflow | Wax-up or Straumann | ||||
| CARES® Visual, Dental | |||||
| Wings software using the | |||||
| Straumann CARES | |||||
| Visual Plug-In and | |||||
| 3Shape | Wax-up or Straumann | ||||
| CARES® Visual, Dental | |||||
| Wings software using the | |||||
| Straumann CARES | |||||
| Visual Plug-In and | |||||
| 3Shape | Wax-up or CAD | Wax-up or Open CAD | |||
| CARES® Visual | Wax-up or Open CAD | ||||
| Abutment | |||||
| Angulation | Up to 30° | Up to 30° | Up to 30° | Up to 30° | Up to 30° |
| Manufacturing | |||||
| Workflow | Straumann Milling | Straumann Milling | Straumann Milling | Traditional casting or | |
| pressing or Straumann | |||||
| Milling | Traditional casting or | ||||
| pressing or Straumann | |||||
| Milling | |||||
| Coping/ Crown | |||||
| Material | Digital materials: | ||||
| coron® | |||||
| zerion® LT | |||||
| zerion® ML and UTML | Digital materials: | ||||
| IPS e.max CAD | |||||
| polycon® ae | Digital materials: | ||||
| zerion® ML and UTML | Cast materials: | ||||
| Type 4 metals (ISO 22674) | |||||
| Base metal alloys (e.g., | |||||
| cobalt-chromium (CoCr)) | |||||
| Noble metal alloys (e.g., | |||||
| gold alloy) |
Press materials:
IPS e.max® Press Ceramic
Digital materials:
coron®
zerion® LT
polycon® ae | Traditional Workflow:
Type 4 Metals (ISO 22674)
IPS e.max® Press Ceramic
Digital Workflow:
polycon® ae (temporary)
zerion® (permanent)
IPS e.max® CAD Ceramic
(permanent)
coron® (permanent) |
| Sterilization
Method | Non-sterile/
End user sterilized | Non-sterile/
End user sterilized | Non-sterile/
End user sterilized | Non-sterile/
End user sterilized | Non-sterile/
End user sterilized |
5
Straumann® BLX Variobase Abutment
510(k) Summary
Table 1 - Comparison of subject device versus reference devices (BLX Variobase Abutments)
6
Straumann® BLX Variobase Abutment
510(k) Summary
5.7 Performance Testing
Sterilization and Shelf Life:
The sterilization process for the BLX Variobase Abutments as recommended in the labeling was validated according to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015" and according to ISO 17655-1, Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices."
Biocompatibility:
Biocompatibility was evaluated according to ISO 10993-1:2009 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and the biocompatibility evaluation flow chart according 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. No new issues of biocompatibility are raised for the subject devices and therefore, no additional biocompatibility testing was required.
Performance Testing Bench:
Dynamic fatique tests for the implant-abutment system were 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 according to ISO 14801, "Dentistry -- Implants -- Dynamic loading test for endosseous dental implants". The test results demonstrated the Straumann® BLX Implant/Variobase final abutment system is equivalent to the predicate and reference devices. The test environment was 0.9% NaCl at 37°.
5.8 Conclusion
The documentation submitted in this premarket notification demonstrates the BLX Variobase Abutments are substantially equivalent to the primary predicate and reference devices.
7
Image /page/7/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 17, 2019
Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K190082
Trade/Device Name: Straumann® BLX Variobase Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: January 16, 2019 Received: January 17, 2019
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.
8
Page 2
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-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,
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