(170 days)
The Straumann n!ce Glass Ceramic A14 Blocks are intended to be ceramic mesostructures cemented to the Ti-base for a two-piece hybrid abutment for single tooth restorations or hybrid abutment crowns, used in conjunction with endosseous dental implant to restore chewing function. The following compatibilities apply:
| Ti-Base | Block | ||
|---|---|---|---|
| manufacturer | system | Reference | interface size |
| Straumann | RC Variobase® for CEREC | 022.0024 | L |
| NC Variobase® for CEREC | 022.0025 | L | |
| RN Variobase® for CEREC | 022.0019 | L | |
| WN Variobase® for CEREC | 022.0020 | L |
Straumann® n!ce® glass ceramic is a proprietary lithium disilicate (Li2O-SiO2) dental glass ceramic material. The n!ce® glass-ceramic A14 blocks feature a pre milled interface that fits the Straumann® Variobase® for CEREC®. The blocks are further processed by the trained professional to make individually designed mesostructure that are milled into the desired shape of a hybrid abutment or hybrid abutment crown using the Sirona inLab (Version3.65) and CEREC® software (Version 4.2). n!ce® mesostructures can be additional crystallization firing. Stain & glaze techniques can be applied.
n!ce® A14 blocks are available in two levels of translucency: HT (High Translucency) and LT (Low Translucency). Both translucencies are available in shades , A1, A2, A3, B2, B4 and C2 for flexibility and application variety to meet individual patient needs. n!ce®A14 blocks are available with one interface size large (L)
The provided text describes the submission for a 510(k) premarket notification for the "Straumann® n!ce Glass Ceramic A14 Blocks," a dental device. It focuses on demonstrating substantial equivalence to a predicate device, rather than outlining acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML medical device.
Therefore, many of the requested items (Acceptance Criteria Table, Sample Size for Test Set, Data Provenance, Number of Experts, Adjudication method, MRMC study, Standalone performance, Training set size, Training set GT establishment) are not applicable to this type of regulatory submission, as it is for a physical dental material block, not an AI/ML algorithm.
However, I can extract the "Performance Data" section which describes the types of tests conducted to support the device's safety and effectiveness and its substantial equivalence.
Here's the information that can be extracted from the document, focusing on what is relevant to "acceptance criteria" and "study."
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" paired with "reported device performance" in the way one might expect for an AI/ML device (e.g., sensitivity, specificity thresholds). Instead, it lists the types of performance tests that were conducted and implied their results supported substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| ISO 6872 compliance | Test data submitted or referenced to support the evaluation of the subject n!ce® Glass-Ceramic A14 Blocks, indicating compliance with ISO 6872 (Dentistry-Ceramic materials). |
| ISO 14801 compliance | Test data submitted or referenced, indicating compliance with ISO 14801 (Dentistry-Implants-Dynamic fatigue test for endosseous dental implants). |
| FDA guidance compliance | Test data submitted or referenced, indicating compliance with FDA guidance "Root-form endosseous dental implants and endosseous dental implant abutments." |
| ISO 7991 compliance | Test data submitted or referenced, indicating compliance with ISO 7991 (Glass—Determination of coefficient of mean linear thermal expansion). |
| ISTA 2A compliance | Transport and package testing per ISTA 2A and the standards referenced therein was submitted or referenced. |
| Sterilization effects | Effects of steam sterilization on product performance consistent with FDA guidance "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling, Guidance for Industry and Food and Drug Administration Staff, Appendix C" were evaluated. |
| Steam sterilization | Steam sterilization validation per ISO 17665 series standards was conducted. |
| Biocompatibility | Biocompatibility assessment per the ISO 10993 series of standards was conducted. |
| Chemical characterization | Chemical characterization per ISO 10993-18 (Biological evaluation of medical devices—Part 18: Chemical characterization of materials) was conducted. |
| Shelf life | Evaluation of shelf life per ASTM F1980 (Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices) was conducted. |
| Processing/Machinability | Laboratory processing including Workflow validation, and Machinability of blocks were performed. "The compatibility of the n!ce glass blocks with the existing IPS e.max CAD milling program is validated as part of this submission." (Implies successful milling and processing according to existing dental CAD/CAM systems). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to various standards and guidances but does not detail the specific sample sizes or the provenance of the data for each test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the document describes a physical dental material, not an AI/ML device requiring expert-established ground truth for a diagnostic task.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the document describes a physical dental material.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable as the document describes a physical dental material.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the document describes a physical dental material.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable in the context of an AI/ML diagnostic device. For the dental material, "ground truth" would relate to its physical, chemical, and mechanical properties as defined by relevant ISO and ASTM standards and confirmed through laboratory testing.
8. The sample size for the training set
This is not applicable as the document describes a physical dental material, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as the document describes a physical dental material.
{0}------------------------------------------------
Image /page/0/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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 1, 2017
Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs and Quality Straumann USA. LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K171773
Trade/Device Name: Straumann® n!ce Glass Ceramic A14 Blocks Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: November 2, 2017 Received: November 3, 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
{1}------------------------------------------------
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 (OS) regulation (21 CFR Part 820); 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,
Andrew I. Steen -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
Straumann n!ce Glass-Ceramic A14 Blocks
The Straumann n!ce Glass Ceramic A14 Blocks are intended to be ceramic Indications for Use (Describe) mesostructures cemented to the Ti-base for a two-piece hybrid abutment for single tooth restorations or hybrid abutment crowns, used in conjunction with endosseous dental implant to restore chewing function. The following compatibilities apply:
| Ti-Base | Block | ||
|---|---|---|---|
| manufacturer | system | Reference | interface size |
| Straumann | RC Variobase® for CEREC | 022.0024 | L |
| NC Variobase® for CEREC | 022.0025 | L | |
| RN Variobase® for CEREC | 022.0019 | L | |
| WN Variobase® for CEREC | 022.0020 | L |
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)
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."
Page 1 of 1
{3}------------------------------------------------
1. 510(k) Summary
| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG)60 Minuteman RoadAndover, MA 01810Registration No.: 1222315 Owner/Operator No.: 9005052 |
|---|---|
| Contact Person: | Jennifer Jackson, MSHead of Regulatory Affairs and Quality(978) 747-2509 |
| Prepared By: | Shokoufeh KhodabandehRegulatory Affairs and Compliance ManagerInstitut Straumann AG+41 61 965 1260 |
| Date Prepared: | December 1, 2017 |
| Product Code(s): | NHA (21 CFR 872.3630) |
| Device Class: | II (21 CFR 872.3630) |
| Classification Panel: | Dental |
| Classification Name: | Endosseous Dental Implant Abutment (21 CFR 872.3630) |
| Proprietary Name: | Straumann® n!ce Glass Ceramic A14 Blocks. |
| Predicate Device: | K132209 IPS e.max CAD Abutment Solutions ( IvoclarVivadent, Inc.) |
| Reference Device(s): | K160262 n!ce Glass Ceramic Blocks ( Institut Straumann AG)K151324, Variobase® for CEREC® (Institut Straumann AG)K170354, Variobase® with n!ce™ Restorations (InstitutStraumann AG) |
| Device Description: | Straumann® n!ce® glass ceramic is a proprietary lithiumdisilicate (Li2O-SiO2) dental glass ceramic material. The n!ce®glass-ceramic A14 blocks feature a pre milled interface that fitsthe Straumann® Variobase® for CEREC®. The blocks arefurther processed by the trained professional to makeindividually designed mesostructure that are milled into thedesired shape of a hybrid abutment or hybrid abutment crownusing the Sirona inLab (Version3.65) and CEREC® software(Version 4.2). n!ce® mesostructures can be |
{4}------------------------------------------------
additional crystallization firing. Stain & glaze techniques can be applied.
n!ce® A14 blocks are available in two levels of translucency: HT (High Translucency) and LT (Low Translucency). Both translucencies are available in shades , A1, A2, A3, B2, B4 and C2 for flexibility and application variety to meet individual patient needs. n!ce®A14 blocks are available with one interface size large (L)"
The n!ce glass-ceramic A14 blocks are intended to be used to Intended Use: manufacture mesostructure cemented to Ti-Bases as part of a two-piece abutment or abutment crown, which are placed onto dental implants.
Indications For Use: The Straumann n!ce Glass Ceramic A14 Blocks are intended to be ceramic mesostructures cemented to the Ti-base for a twopiece hybrid abutment for single tooth restoerations or hybrid abutment crowns, used in conjunction with endosseous dental implant to restore chewing function. The following compatibilities apply:
| Ti-Base | Block | ||
|---|---|---|---|
| manufacturer | system | Reference | interface size |
| Straumann | RC Variobase® for CEREC | 022.0024 | L |
| NC Variobase® for CEREC | 022.0025 | L | |
| RN Variobase® for CEREC | 022.0019 | L | |
| WN Variobase® for CEREC | 022.0020 | L |
Materials: Lithium Disilicate reinforced Lithium Aluminosilicate Glass-Ceramic
{5}------------------------------------------------
Technological Characteristics:
A comparison of the relevant technological characteristics between the subject and primary predicate devices is provided in the table that follows.
| Primary Predicate Device | Subject DevicesStraumann® n!ce GlassCeramic A14 Blocks | EquivalenceDiscussion | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Feature | IPS e.max CAD AbutmentSolutions (K132209) | ||||||||||||||||||||||
| Indications ForUse | IPS e.max CAD AbutmentSolutions is intended for use inpartially or fully edentulousmandibles and maxillae in supportof single cementretainedrestorations. The systemcomprises three parts: IPS e.maxCAD ceramic structure, Ti baseand CAD/CAM software. The IPSe.max CAD ceramic structurecemented to the Ti base isrecommended for two-piecehybrid abutments for single toothrestorations and hybrid abutmentcrowns, used in conjunction withendosseous dental implants. | The Straumann n!ce GlassCeramic A14 Blocks areintended to be ceramicmesostructures cemented tothe Ti-base for a two-piecehybrid abutment for singletooth restorations or hybridabutment crowns, used inconjunction with endosseousdental implant to restorechewing function. Thefollowing compatibilitiesapply:Ti-Basemanufacturer system Reference Blockinterface size Straumann RC Variobase® for CEREC 022.0024 L NC Variobase® for CEREC 022.0025 L RN Variobase® for CEREC 022.0019 L WN Variobase® for CEREC 022.0020 L | EquivalentThe indications for then!ce Glass Ceramic A14Blocks are within theindications of the IPSe.max CAD material.The Compatibility to NCand RC is covereddirectly by the predicatedevice.Compatibility to WN andRN is supported by thereference device perK151324, Variobase® forCEREC® (InstitutStraumann AG) | ||||||||||||||||||||
| Block Dimensions | A14 (12.4 x 14.5 x 18.0 mm)A16 (17.8 x 15.8 x 18.0 mm ) | A14 (12.4 x 14.5 x 18.0 mm) | EquivalentThe n!ce material isbeing offered in the A14size which is also offeredfor IPS e.max CAD.n!ce material is notoffered in A16 block sizeat this point. | ||||||||||||||||||||
| Pre-milled TiBaseinterface (screwchannel hole) | Sizes: Large (L)Small (S) | Sizes: Large (L) | EquivalentThe n!ce material isbeing offered with Lscrew channel size whichis also offered for IPSe.max CADn!ce material is notoffered with (s) screwchannel at this point |
Table 1 – Summary of the subject device and primary predicate device characteristic
{6}------------------------------------------------
| Feature | Primary Predicate DeviceIPS e.max CAD AbutmentSolutions (K132209) | Subject DevicesStraumann® n!ce GlassCeramic A14 Blocks. | EquivalenceDiscussion |
|---|---|---|---|
| ChemicalComposition | lithium disilicate glass Ceramic | lithium disilicate – lithiumaluminosilicate reinforcedglass ceramic | EquivalentBoth materials are in thefamily of lithiumdisilicate glasses |
| CrystallizationState asSupplied | Partially crystallized; finalcrystallization done by dentallaboratory | Fully Crystalized | EquivalentBoth materials are fullycrystallized when fittedin the patient's mouth |
| Mandrel Design | The mandrel is designed to becompatible with the materialholders present on mills marketedby Sirona under the trade namesCEREC and inLab and other third-party mills. | The mandrel is designed to becompatible with the materialholders present on millsmarketed by Sirona under thetrade names CEREC andinLab and other third-partymills. | EquivalentBoth the subject andpredicate designs can beeffectively processed inmills designed to mate tothe Sirona style mandrel. |
| Minimum WallThickness | 1.0 mm | 1.0 mm | Identical |
| MaximumMesostructureAngulation | 20° | 20° | Identical |
| Design Workflow | Per the Sirona CEREC InLab, software version 3.6 and CerecSW (Version 4.2) | IdenticalPlease note n!ce is NOTa new material added tosoftware. We claimcompatibility with theexisting software clearedfor IPS e.max CAD | |
| ManufacturingWorkflow | Per the Sirona CEREC MC X and MC XL milling systems | Identical | |
| Feature | Primary Predicate DeviceIPS e.max CAD AbutmentSolutions (K132209) | Subject Devices | EquivalenceDiscussion |
| Compatible ti-bases | NBRS 3.5NBRS 4.3NBRS 5.0NBRS 6.0NB A 4.5NB A 5.0 SBL 3.3 SBL 4.1B C 3.4B C 4.1B C 5.0 | RC Variobase® for CERECNC Variobase® for CERECRN Variobase® for CERECWN Variobase® for CEREC | EquivalentCompatibility ofpredicate device toStraumann Variobase®for CEREC is supportedby the reference deviceper K151324,Variobase® for CEREC®(Institut Straumann AG) |
| Compatible ti-base platformdiameters | Not disclosed | NC:4.5 mmRC:4.6 mmRN:5.0 mmWN:7.0 mm | EquivalentCompatibility of predicatedevice toStraumann Variobase®for CEREC is supportedby the reference deviceper K151324,Variobase® forCEREC® (InstitutStraumann AG) |
{7}------------------------------------------------
{8}------------------------------------------------
| Feature | Refernce Device DeviceVariobase for CEREC(K151324) | Subject DevicesStraumann® n!ce GlassCeramic A14 Blocks | EquivalenceDiscussion | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Indications ForUse | The Straumann® Variobase® forCEREC® are titanium alloyabutments placed onto Straumanndental implants to provide supportfor customized prostheticrestorations. Straumann®Variobase® for CEREC®abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridgerestorations.All digitally designed copingsand/or crowns for use with theStraumann® Variobase® forCEREC® abutments are to bedesigned using Sirona inLabsoftware (Version 3.65) or SironaCEREC Software (Version 4.2)and manufactured using a SironaCEREC or inLab MC X or MC XLmilling unit. | The Straumann n!ce GlassCeramic A14 Blocks areintended to be ceramicmesostructures cemented tothe Ti-base for a two-piecehybrid abutment for singletooth restorations or hybridabutment crowns, used inconjunction with endosseousdental implant to restorechewing function. Thefollowing compatibilitiesapply:Ti-Base manufacturer system Reference Block interface size Straumann RC Variobase® for CEREC 022.0024 L NC Variobase® for CEREC 022.0025 L RN Variobase® for CEREC 022.0019 L WN Variobase® for CEREC 022.0020 L | EquivalentStraumann n!ce glassceramic was shown to besubstantially equivalentto IPS e.max CAD perK170354 cleared onJune 7, 2017. | ||||||||||||||||||||
| Ti-base Material | Titanium-Aluminum-Niobium alloy (Ti-6Al-7Nb) | IdenticalSame Ti-base is used forsubject device | |||||||||||||||||||||
| Ti-base Diameter(base) | NC: 4.5 mmRC: 4.6 mmRN: 5.0 mmWN: 7.0 mm | IdenticalSame Ti-base is used forsubject device | |||||||||||||||||||||
| Ti-base postheight | 4.7 mm | IdenticalSame Ti-base is used forsubject device | |||||||||||||||||||||
| Ti-base gingivaheight | NC: 0.65 mmRC: 0.85 mmRN and WN: N/A - defined by the neck of the tissue level implant | IdenticalSame Ti-base is used forsubject device |
Table 2 – Substantial Equivalence Comparison with reference device Variobase for CEREC (K151324)
{9}------------------------------------------------
| Feature | Refernce DeviceVariobase for CEREC(K151324) | Subject DevicesStraumann® n!ce GlassCeramic A14 Blocks | EquivalenceDiscussion |
|---|---|---|---|
| Coping/ CrownMaterial | Compatible with any millingblanks cleared for use with theCEREC MC X and MC XLmilling systems (i.e., containingthe pre-machined mountinghole). Currently available:inCoris ZI meso (K123664)Ivoclar IPS e.maxCAD(K132209)Ivoclar Telio CAD (K093708) | Straumann n!ce Glass Ceramic | EquivalentStraumann n!ce glassceramic was shown to besubstantially equivalentto IPS e.max CAD perK170354 cleared onJune 7, 2017.The compatibility of then!ce glass blocks withthe existing IPS e.maxCAD milling program isvalidated as part of thissubmission |
| Angulation | 20° | 20° | Identical |
| CompatibleCAD software | Sirona inLab software (Version 3.65) or Sirona CEREC Software(Version 4.2) | Identical | |
| Compatiblemilling unit | Sirona CEREC or inLab MC X or MC XL milling unit. | Identical |
{10}------------------------------------------------
| Performance Data: | Test data to support the evaluation of the subject n!ce® | |
|---|---|---|
| Glass- Ceramic A14 Blocks has been submitted or | ||
| referenced as follows: |
- Product performance testing per ISO 6872, Dentistry-Ceramic materials, ISO 14801, Dentistry-Implants-Dynamic fatigue test for endosseous dental implants, FDA guidance Root-form endosseous dental implants and endosseous dental implant abutments and ISO 7991, Glass—Determination of coefficient of mean linear thermal expansion.
- Transport and package testing per ISTA 2A and ● the standards referenced therein.
- Effects of steam sterilization on product performance consistent with FDA guidance Reprocessing Medical Devices in Health Care Setting: Validation Methodsand Labeling, Guidance for Industry and Food and Drug Administration Staff, Appendix C.
- Steam sterilization validation per ISO 17665 series ● standards
- Biocompatibility assessment per the ISO 10993 series of standards.
- Chemical characterization per ISO 10993-18, Biological . evaluation of medical devices—Part 18: Chemical characterization of materials.
- Evaluation of shelf life per ASTM F1980, Standard Guide . for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
- . Laboratory processing including Workflow validation, and Machinability of blocks
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.
§ 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.)