CALC-I-OSS

K042583 · Ultradent Products, Inc. · LYC · Jul 19, 2005 · Dental

Device Facts

• Record ID: K042583
• Device Name: CALC-I-OSS
• Applicant: Ultradent Products, Inc.
• Product Code: LYC · Dental
• Decision Date: Jul 19, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

calc-i-oss is a synthetic, resorbable, osteoconductive bone graft substitute composed of beta-tricalcium phosphate (β-TCP). It is provided as porous, spherical granules (315–1600 μm) with an interconnecting microstructure. The device is used by dental surgeons in clinical settings to fill or augment osseous defects in the oral and maxillofacial region. The material acts as a scaffold for new bone formation, gradually resorbing over time. It is applied directly to the surgical site, often in conjunction with membranes or autologous bone to facilitate guided bone regeneration. The device provides a biocompatible, osteoconductive matrix to support natural healing and bone repair in dental procedures.

Clinical Evidence

Bench testing only. Evidence includes material characterization, chemical purity analysis, and porosity/resorption studies. Biocompatibility is supported by established literature on β-TCP. Sterilization validation performed per ISO 11137 to achieve a sterility assurance level (SAL) of 10^-6.

Technological Characteristics

Material: >99% phase-pure synthetic β-tricalcium phosphate. Form: Porous spherical granules. Particle size: 315–1600 μm. Microstructure: Interconnecting porosity (58%). Sterilization: ISO 11137 (SAL < 10^-6).

Indications for Use

Indicated for patients requiring bone grafting in intraoral/maxillofacial osseous defects, including periodontal defects, furcation defects, alveolar ridge augmentation, tooth extraction sites, sinus floor elevations, and defects following cyst removal or apicoectomy. Used alone or in combination with autologous bone and membranes.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Cerasorb Dental (P800035)

Submission Summary (Full Text)

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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 and<br>Synthetic 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,<br>Augmentation of alveolar crest, possibly in<br>combination with autologous bone and<br>membrane (i.e. guided bond regeneration.)<br>Indicated for apicoectomy and extraction<br>defects in combination with membranes.<br>Indicated for filling of defects after surgical<br>removal of retained teeth Sinus floor<br>elevations and for defects after removal of<br>autologous bone. | Indicated for defects after removal of cysts;<br>repair of marginal and periapical periodontal<br>alveolar bony pockets as well as bifurcations<br>and trifurcations of the teeth; augmentation of<br>the atrophied alveolar ridge; alveolar<br>augmentation of mandibular and maxillary<br>ridges; defects after apicoectomy; and filling<br>bone defects after surgical resection of impacted<br>teeth (without implantation). |
| CHEMICAL<br>COMPOSITION<br>& PURITY: | > 99% Phase-pure synthetic β-tricalcium<br>phosphate. | > 99% Phase-pure synthetic β-tricalcium<br>phosphate. |
| FORM: | High purity β-tricalcium phosphate porous<br>spherical granules. | High purity β-tricalcium phosphate porous<br>spherical granules. |
| PARTICLE SIZE<br>AND RANGE<br>(μm): | Granulate size range from 315 – 1600. | Granulate size range 500-1000. |
| POROSITY /<br>RESORPTION: | Interconnecting porous material 58% for high<br>level of resorption. Refer to the enclosed<br>Solubility Report for more information on<br>porosity as well as resorption. | Interconnecting porous material 22% for high<br>level of resorption. Refer to the enclosed<br>Solubility Report for more information on<br>porosity as well as resorption. |

### Predicate Comparison Table

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#### Device Description: 4.

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.

#### 5. Intended Use:

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.

#### 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 reports<br>and technical data of this submission. |
| Adverse Tissue Reaction | See attached confidential test reports and technical data of this<br>submission. Note: β-TCP is known to be highly biocompatible,<br>resorbable and osteoconductive. Numerous articles on safety and<br>effectiveness are available concerning indications for use in<br>dentistry and are noted in the literature. Mitigation concerning<br>infection 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 use<br>and 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 [phone] 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 [phone] 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

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