calc-i-oss is indicated for the filling and/or augmentation of intraoral/maxillofacial osseous defects, such as intrabony periodontal osseous defects, furcation defects, augmentation of bony defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation grafting.

Device Description

calc-i-oss is a synthetic resorbable osteoconductive bone graft substitute composed of tricalcium phosphate. The device is intended for dental intraosseous, oral, and cranio-/maxillofactial bony defects.

AI/ML Overview

This document describes the calc-i-oss device, an osteoconductive bone void filler and synthetic resorbable bone graft material. As a 510(k) submission, the primary goal is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove the device meets specific acceptance criteria through a standalone study in the traditional sense of a clinical trial.

Therefore, the "acceptance criteria" here refers to the characteristics and performance expected of the device to be considered substantially equivalent to the predicate. The "study" proving it meets these "acceptance criteria" is primarily a comparison to the predicate device and internal testing data to confirm the device's properties.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) submission, the "acceptance criteria" are implicitly derived from the characteristics of the predicate device (Cerasorb Dental) and general safety/performance expectations for this class of device. The "reported device performance" is the description of the calc-i-oss device itself.

Acceptance Criteria (from Predicate/General Device Type)	Reported calc-i-oss Device Performance
Indications for Use:	Indicated for defects after removal of cysts, Augmentation of alveolar crest (possibly with autologous bone and membrane), Apicoectomy and extraction defects (with membranes), Filling of defects after surgical removal of retained teeth, Sinus floor elevations, Defects after removal of autologous bone.
Chemical Composition:	> 99% Phase-pure synthetic β-tricalcium phosphate.
Form:	High purity β-tricalcium phosphate porous spherical granules.
Particle Size and Range (μm):	Granulate size range from 315 – 1600 μm.
Porosity / Resorption:	Interconnecting porous material 58% for high level of resorption. (Refer to enclosed Solubility Report for more information on porosity as well as resorption).
Biocompatibility:	β-TCP is known to be highly biocompatible, resorbable, and osteoconductive. (See attached confidential test reports and technical data, and literature references).
Sterility:	SAL < 10^-6 per ISO 11137. (See attached report).
Risk Mitigation:	Risks like "Ineffective Bone Formation" (mitigated by material characterization), "Adverse Tissue Reaction" (mitigated by biocompatibility data and literature), "Infection" (mitigated by sterilization), and "Improper Use" (mitigated by labeling/instructions) were identified and addressed.

2. Sample Size for the Test Set and Data Provenance

The provided text does not describe a specific clinical "test set" in the context of a prospective clinical study with human subjects. Instead, the evidence for substantial equivalence relies on:

Material Characterization: "confidential test reports and technical data" (likely laboratory-based, mechanical, chemical, and biological testing as per ISO standards for biomaterials).
Literature Review: "Numerous articles on safety and effectiveness are available concerning indications for use in dentistry and are noted in the literature" for β-TCP.
Comparison to Predicate: Direct comparison of the new device's characteristics (composition, form, particle size, porosity, indications) to the legally marketed Cerasorb Dental.

Therefore, phrases like 'sample size for the test set' or 'data provenance (e.g. country of origin)' are not directly applicable to a traditional clinical study as detailed in this 510(k) summary. The "data" referenced is primarily pre-clinical/bench testing and comparison to an established predicate.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This question is also not applicable to the presented 510(k) submission. There is no mention of a "test set" requiring expert consensus for ground truth, nor is there any description of expert qualifications for such a process. The "ground truth" for a 510(k) primarily relates to the established safety and effectiveness of the predicate device and the scientific validity of the pre-clinical tests performed on the new device.

4. Adjudication Method for the Test Set

Since no clinical "test set" involving human data and expert review is described, an adjudication method (such as 2+1 or 3+1) is not applicable to this submission.

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 question is not applicable. The calc-i-oss device is a bone graft substitute material, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or described.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not applicable. The calc-i-oss device is a biomaterial, not an algorithm or software device.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is established through:

Material Specifications: Chemical composition (>99% phase-pure synthetic β-tricalcium phosphate), physical properties (round macrostructure, specific granulate size range, 58% interconnecting porosity).
Predicate Device Characteristics: The established safety and performance profile of the legally marketed Cerasorb Dental (P800035).
Scientific Literature/Clinical Experience: The general understanding and widespread use of β-tricalcium phosphate as a biocompatible, resorbable, and osteoconductive material in dentistry.
Bench Testing Data: "confidential test reports and technical data" that confirm the device's specified properties (e.g., sterilization efficacy, solubility/resorption characteristics, material characterization).

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of an AI/machine learning model for this biomaterial device submission.

9. How the Ground Truth for the Training Set was Established

This question is not applicable as there is no training set for an AI/machine learning model.

Summary

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This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92 and supports the conclusion of SE for calc-i-oss noted below.

Applicant's Name and Address: 1.

JUL 1 9 2005

Ultradent Products, Inc.
--------------------------

505 West 10200 South
----------------------

South Jordan, Utah 84095
--------------------------

Telephone number:	801-553-4200
Fax number:	801-572-0600
Contact Person:	Tammy Lavery
	RA/QA/QC Senior Manager

Name of the Device: 2.

Tradename:	calc-i-oss
Common Name:	Osteoconductive Bone Void Filler andSynthetic Resorbable Bone Graft Material
Classification:	II (21CFR 872.3930)

Legally Marketed Predicate Devices to which Equivalence is Claimed: 3.

Predicate Device Identified: Cerasorb Dental (P800035).

	calc-i-oss	Legally marketed Cerasorb (Dental)

INDICATIONS:	Indicated for defects after removal of cysts,Augmentation of alveolar crest, possibly incombination with autologous bone andmembrane (i.e. guided bond regeneration.)Indicated for apicoectomy and extractiondefects in combination with membranes.Indicated for filling of defects after surgicalremoval of retained teeth Sinus floorelevations and for defects after removal ofautologous bone.	Indicated for defects after removal of cysts;repair of marginal and periapical periodontalalveolar bony pockets as well as bifurcationsand trifurcations of the teeth; augmentation ofthe atrophied alveolar ridge; alveolaraugmentation of mandibular and maxillaryridges; defects after apicoectomy; and fillingbone defects after surgical resection of impactedteeth (without implantation).
CHEMICALCOMPOSITION& PURITY:	> 99% Phase-pure synthetic β-tricalciumphosphate.	> 99% Phase-pure synthetic β-tricalciumphosphate.
FORM:	High purity β-tricalcium phosphate porousspherical granules.	High purity β-tricalcium phosphate porousspherical granules.
PARTICLE SIZEAND RANGE(μm):	Granulate size range from 315 – 1600.	Granulate size range 500-1000.
POROSITY /RESORPTION:	Interconnecting porous material 58% for highlevel of resorption. Refer to the enclosedSolubility Report for more information onporosity as well as resorption.	Interconnecting porous material 22% for highlevel of resorption. Refer to the enclosedSolubility Report for more information onporosity as well as resorption.

Predicate Comparison Table

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Device Description: 4.

5. Intended Use:

Technological Characteristics: 6.

a. Chemical Composition:

calc-i-oss is a granulate consisting of bioresorbable, medical grade beta tricalcium phosphate and used for the filling of bone defects. (Refer to confidential test reports and data attached.)

b. Physical Properties:

calc-i-oss has a round macrostructure. Granulate sizes range between 315 and 1600 um. calc-i-oss is characterized by a porous and interconnecting microstructure. (Refer to confidential test reports and data attached.)

Risk Analysis and Test Methods: 7.

The risks noted below were identified and considered during the design of the product. Testing and/or actions were identified to mitigate each area of possible concern.

Identified Risk	Mitigation
Ineffective Bone Formation	Material Characterization - See attached confidential test reportsand technical data of this submission.
Adverse Tissue Reaction	See attached confidential test reports and technical data of thissubmission. Note: β-TCP is known to be highly biocompatible,resorbable and osteoconductive. Numerous articles on safety andeffectiveness are available concerning indications for use indentistry and are noted in the literature. Mitigation concerninginfection is also addressed below.
Infection	Sterilization (SAL < 10-6) per ISO 11137. See attached report.
Improper Use	Labeling - Refer to the section for labeling and instructional useand warnings.

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Substantial Equivalence: 8.

In conclusion and per the review noted above, the calc-i-oss manufactured and In conclusion and per the review notes are., 2000 South, South Jordan, Utah marketed by Offradent Froduces, the, 500 - Woomarketed device: Cerasorb (Dental)
84095, is substantially equivalent to the legally-marketed device for seme intended 84095, is substantially equivalent to the regarly maniete and material for same intended use.

Tammy Lavery RA/QA/QC Senior Manager Date

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

SEP 1 3 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Tammy Lavery Regulatory Affairs Senior Manager Ultradent Products, Incorporated 505 West 10200 South South Jordan, Utah 84095

Re: K042583 Trade/Device Name: Calc-i-oss Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: July 6, 2005 Received: July 7, 2005

Dear Ms. Lavery:

This letter corrects our substantially equivalent letter of July 19, 2005.

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 mendments or to devices that have been reclassified in accordance with the provisions of Amendinents of to actives and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls approval (1 MI ). provisions stration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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 (1 vir 1) an he 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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Page 2 - Ms. Lavery

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s Issualice of a successor players with other requirements
mean that FDA has made a determination that your devices with other Federal agencies mean that FDA has made a decerminations administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by registration of the Act or any rederal statues and reguirements, including, but not limited to: registration
You must comply with all the Act's requirements and monufacturing practice You must comply with an the Act 3 requirements; massaling
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 807), labelling (21 CFR Part 807), as 12 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulations 531 542 of the Ar requirements as set form in the quality systems (20) regarders (sections 531-542 of the Act);
applicable, the electronic product radiation control provisions (sections 531-54 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section This letter will allow you to continue marketing your dostantial equivalence of your device to
510(k) premarket notification. The FDA finding of substantial equivaleriae and 510(K) premarket nothleation. The I DA Intentig or successfication for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 1991
(2001), 1978 (2007), 1949-19-19 10, 2016 n you desire spee of Compliance at (240) 276-0115 please contact the Office of Comphanee at (210) = 0 compulsion structure). Also, please
(http://www.fda.gov/cdrh/organiz.html#OC_for OC organizations bat notification" (21 C (http://www.lda.gov/curinorgamiz.nam/>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> note the regulation entitled, "Misorananing of 1915. Constitution on your responsibilities under the Part 807.97). You may other general international and Consumer Assistance at its
Act from the Division of Small Manufacturers, International and Consumer address Act from the Drvision of Billan I an (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Signature

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

KO42583

510(k) Number (if known): Unknown

Device Name:

Indications For Use:

Defects after removal of bone cysts, Periodontal defects in combination with membranes, I crodonal deleces in combination with autologous bone and membrane (Guided Bone Regeneration) Apicoectomy Extraction defects in combination with membranes Defects after surgical removal of retained teeth Sinus floor elevations Defects after removal of autologous bone

X Prescription Use_ (Per 21 801 CFR Subpart D) AND/OR

Over-The-Counter Use (Per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

A. Betz, DDS for Dr. Susan Remmer

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number

Page 1 of (Posted November 13, 200

Regulation Number and Section

§ 872.3930 Bone grafting material.

(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.