Who is the manufacturer of n!ce for Planmill?

Institut Straumann AG filed the 510(k) submission for n!ce for Planmill (K173410).

What is the FDA product code for n!ce for Planmill?

EIH. It is classified under 21 CFR 872.6660 as a Class 2 device in the Dental panel.

What is the regulatory pathway for n!ce for Planmill?

510(k) clearance (submission type: Special).

What are the predicate devices for n!ce for Planmill?

n!ce Glass Ceramic Blocks (K160262).

Who can help prepare an FDA 510(k) submission like n!ce for Planmill?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

n!ce for Planmill

K173410 · Institut Straumann AG · EIH · Nov 14, 2017 · Dental

Device Facts

Record ID	K173410
Device Name	n!ce for Planmill
Applicant	Institut Straumann AG
Product Code	EIH · Dental
Decision Date	Nov 14, 2017
Decision	SESE
Submission Type	Special
Regulation	21 CFR 872.6660
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The n!ce® glass ceramic is intended to be used to manufacture ceramic restorations for the restoration of natural teeth or on top of abutments.

Device Story

n!ce for Planmill is a lithium disilicate glass-ceramic block used to manufacture dental prosthetic restorations. The device consists of a glass-ceramic block bonded to a mandrel compatible with Planmill milling equipment. Dentists or dental technicians use CAD/CAM milling systems to transform the block into specific restorations, including inlays, onlays, veneers, partial crowns, and crowns. The final restoration is placed on natural teeth or dental implant abutments. The device provides a restorative material for dental professionals to improve patient oral function and aesthetics.

Clinical Evidence

No clinical data. Evidence consists of bench testing including ISO 6872 (dental ceramic materials), ISO 7991 (thermal expansion), ISO 10993-1/5/18 (biocompatibility/cytotoxicity), ISTA 2A (transport), ASTM F1980 (shelf life), and simulated use validation (machinability and mandrel-block adhesion).

Technological Characteristics

Lithium aluminosilicate ceramic reinforced with lithium disilicate glass-ceramic. Dimensions: C14 (12.4 x 14.5 x 18.0 mm). Mandrel material: AlSi1Sn1MgBi alloy. Fully crystallized state. Complies with ISO 6872 (Type II, Class 2), ISO 7991, and ISO 10993 standards.

Indications for Use

Indicated for use as inlays, onlays, veneers, partial crowns and crowns once finalized into a suitable design.

Regulatory Classification

Identification

Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.

Predicate Devices

n!ce Glass Ceramic Blocks (K160262)

Reference Devices

n!ce for Armann Girrbach (K170420)

Related Devices

K160262 — n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks, · Institut Straumann AG · Sep 16, 2016
K080479 — DENTAL CERAMIC · Dmg USA, Inc. · May 21, 2008
K153130 — Initial LiSi Block · GC America, Inc. · Sep 13, 2016
K170420 — n!ce Glass Ceramic Blocks for Amann Girrbach · Institut Straumann AG · Mar 2, 2017
K202952 — Amber Mill Q Series & Amber Mill Direct Series · Hass Corp. · Aug 26, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The Department of Health & Human Services logo is a stylized image of a human figure. November 14, 2017 Institut Straumann AG % Jennifer Jackson Director. Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01801 Re: K173410 Trade/Device Name: n!ce for Planmill Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: October 30, 2017 Received: November 1, 2017 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. 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); {1}------------------------------------------------ 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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, Image /page/1/Picture/5 description: The image shows the name "Mary S. Runner -S" in a clear, sans-serif font. The text is horizontally oriented and appears to be part of a document or label. The background is plain, which makes the text stand out prominently. 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) or tap here to enter text Device Name n!ce® for Planmill Indications for Use (Describe) Once finalized into a suitable design, the n!ce® glass-ceramic blocks are indicated for use as inlays, onlays, veneers, partial crowns and crowns. Type of Use (Select one or both, as applicable) 区 Prescription Use (Part 21 CFR 801 Subpart D) □ Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 5. 510(k) Summary K173410 | Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG) 60 Minuteman Road Andover, MA 01810 Registration No.: 1222315 Owner/Operator No.: 9005052 | |----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Jennifer M. Jackson, MS Director of Regulatory Affairs and Quality +1 (978) 747-2509 | | Prepared By & Secondary Contact: | Shokoufeh Khodabandeh Regulatory Affairs and Compliance Manager Institut Straumann AG +41 61 965 1260 | | Date Prepared: Product Code(s): | November 10, 2017 EIH | | Device Class: | II | | Classification Panel: | Dental | | Classification Name: | Porcelain powder for clinical use (21 CFR 872.6660) | | Common Name: | Porcelain powder for clinical use (21 CFR 872.6660) | | Proprietary Name: Predicate Device(s): | n!ce® for Planmill K160262 n!ce Glass Ceramic Blocks; Manufacturer Straumann | | Reference Device(s): | K170420; n!ce for Armann Girrbach;Institut Straumann AG | | Device Description: | Straumann® n!ce™ glass ceramic is a proprietary lithium disilicate (Li2O-SiO2) glass ceramic material intended to be milled to produce prosthetic restorations for natural and endosseous dental implant abutment borne teeth. The material is suitable for use in inlays, onlays, veneers, copings and monolithic crown restorations. The mandrel bonded to the blocks is compatible with Planmill milling equipment. | | Intended Use | The n!ce® glass ceramic is intended to be used to manufacture ceramic restorations for the restoration of natural teeth or on top of abutments. | | Indications For Use: | Once finalized into a suitable design, the n!ce® glass-ceramic blocks are indicated for use as inlays, onlays, veneers, partial crowns and crowns. | | Materials: | lithium aluminosilicate ceramic reinforced with lithium disilicate glass-ceramic material (exact same material as previously cleared under K160262) | | Technological Characteristics: | A comparison of the relevant technological characteristics between the subject and the primary predicate is provided in the table that follows. | {4}------------------------------------------------ | Feature | Subject Device n!ce Blocks for Planmill | Primary Predicate Devices Straumann n!ce Glass Ceramic Blocks (K160262) | Equivalence discussions | |---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indication for use | Once finalized into a suitable design, the n!ce® glass-ceramic blocks are indicated for use as inlays, onlays, veneers, partial crowns and crowns. | | Identical | | Block Chemical Composition | lithium aluminosilicate ceramic reinforced with lithium disilicate glass- ceramic material | lithium disilicate – lithium aluminosilicate glass-ceramic material | Identical Same material with a name change | | Crystallization State as Supplied | Fully crystallized | | Identical | | Esthetic Characteristics | Translucency: Shades: Color Uniformity: Fluorescence: | High Translucency (HT) Low Translucency (LT) HT/LT: 6 A-C Homogenous Present | Identical | | Block Dimensions | C14 (12.4 x 14.5 x 18.0 mm) | | Identical | | Feature | Subject Device n!ce Blocks for Planmill | Primary Predicate Devices Straumann n!ce Glass Ceramic Blocks (K160262) | Equivalence discussions | | Mandrel Design | The mandrel is compatible with material holders of Planmill mills. | The mandrel is compatible with material holders of Sirona CEREC and inLab mills and other third-party mills. | Equivalent Both the subject and predicate designs can be effectively processed in the mills corresponding with the mandrel design. | | Mandrel Material | AlSi1Sn1MgBi Alloy | | Identical | | Minimum Wall Thickness of Milled Restoration | | 1.0 mm | Identical | | Flexural Strength | | Meets ISO 6872 requirements for a Type II, Class 2 dental ceramic material. | Identical | | Radioactivity | | Meets ISO 6872 requirements for a Type II, Class 2 dental ceramic material | Identical | | Chemical Solubility | | Meets ISO 6872 requirements for a Type II, Class 2 dental ceramic material. | Identical | | Coefficient of Thermal Expansion (CTE) 100- 500°C | | HT: 7.1 x 10-6/K LT: 7.2 x 10-6/K | Identical | | Glass Transition Temperature (Tg) | | HT: 497°C LT: 491°C | Identical | {5}------------------------------------------------ # Performance Data: Test data to support the evaluation of the subject n!ce® Glass-Ceramic Blocks has been submitted or included by reference as follows: {6}------------------------------------------------ - . Product performance testing per ISO 6872, Dentistry-Ceramic materials - ISO 7991, Glass—Determination of coefficient of mean . linear thermal expansion. - . Biocompatibility assessment as follows: - Evaluation per ISO 10993-1, Biological evaluation of o medical devices - Part 1: Evaluation and testing within a risk management process. - Cytotoxicity assessment per ISO 10993-5, Biological o evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity. - Chemical characterization per ISO 10993-18, o Biological evaluation of medical devices—Part 18: Chemical characterization of materials. - . Transport and package testing per ISTA 2A and the standards referenced therein. - Evaluation of shelf life per ASTM F1980, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. - Simulated Use Validation including a machinability . assessment - . Mandrel-block adhesion No animal or human clinical studies were conducted. - Conclusions: Based upon our assessment of the design and applicable performance data, the subject devices have been determined to be substantially equivalent to the identified predicate devices.