Augmentation or reconstructive treatment of the alveolar ridge.
Filling of infrabony periodontal defects.
Filling of defects after root resection, apicoectomy, and cystectomy.
Filling of extraction sockets to enhance preservation of the alveolar ridge.
Elevation of the maxillary sinus floor.
Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).

Cerasorb® DENTAL is recommended for:

Augmentation or reconstructive treatment of the alveolar ridge.
Filling of infrabony periodontal defects.
Filling of defects after root resection, apicoectomy, and cystectomy.
Filling of extraction sockets to enhance preservation of the alveolar ridge.
Elevation of the maxillary sinus floor.
Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).

Cerasorb® Perio is recommended for:

Filling and/or reconstruction of non-infected periodontal bone defects in conjunction with other products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
Filling of infrabony periodontal defects
Filling of single-or multi-wall bone pockets.
Filling of bifurcations and trifurcations

Device Description

Cerasorb® DENTAL, Cerasorb® M DENTAL and Cerasorb® Perio are a sterile, synthetic, ceramic matrix in either granular form (Cerasorb DENTAL), polygonal shaped morsels (Cerasorb M DENTAL) or polygonal broken granulate (Cerasorb Perio). This material consists of pure-phase Beta-Tricalcium Phosphate with a phase purity of > 97% and complies with the ASTM F 1088-04. The devices, when applied to a bony defect, create a matrix of large, smoothly interconnected pores providing an osteoconductive scaffold (Cerasorb DENTAL approx. 65 vol% [total porosity], Cerasorb M DENTAL approx. 65 vol% [total porosity] and Cerasorb Perio approx. 25 vol%). The different designs are managed and controlled by a validated manufacturing process which guarantees batch to batch conformity and reproducibility. Due to their synthetic nature the devices are free of any biological contaminants and are neither locally nor systemically toxic. In contact with vital bone the Cerasorb granules, morsels or granulate is resorbed and gradually replaced by new bone. Cerasorb DENTAL, Cerasorb M DENTAL and Cerasorb Perio are provided in double sterile packaging (sterilized by gamma irradiation) and are for single-use only.

AI/ML Overview

The provided document is a 510(k) premarket notification for Cerasorb® Dental, Cerasorb® M Dental, and Cerasorb® Perio, which are bone grafting materials. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical studies.

Therefore, many of the requested details regarding acceptance criteria, study design, sample size, ground truth, and expert involvement are not explicitly available in this document. The document mainly discusses the intended use, device description, and comparison to predicate devices to establish substantial equivalence.

Here's what can be inferred or stated based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, the "acceptance criteria" are primarily based on demonstrating substantial equivalence to predicate devices. Specific quantitative performance metrics with defined acceptance thresholds for the new device are typically not required or presented in this type of submission. The performance is implied to be similar to the predicate devices.

Acceptance Criterion	Reported Device Performance
Substantial Equivalence to Predicate Devices (General Safety & Effectiveness)	The FDA determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use (implied, as the letter permits marketing).
Biocompatibility	"All materials are biocompatible."
Resorbability and Replacement with New Bone	"In contact with vital bone the Cerasorb granules, morsels or granulate is resorbed and gradually replaced by new bone." (Similar performance claimed for predicate devices).
Material Conformity	"This access. ply with the ASTM F 1088-04." (Refers to the material's compliance with a standard). "The different designs are managed and reproduced by a validated manufacturing process which guarantees batch-to-batch conformity and reproducibility. Due to their synthetic nature, they are neither locally nor systemically toxic."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated as this is a 510(k) submission primarily relying on previous predicate device data and material characterization, not a new clinical trial with a defined "test set" for performance evaluation in the typical sense.
Data Provenance: The document implies reliance on existing data and regulatory clearances for the listed predicate devices (PMA800035, K992416, K040278, K033815, K970321). The devices are manufactured by curasan AG in Kleinostheim, Germany.

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

Number of Experts/Qualifications: Not applicable or provided. This type of submission does not involve a "test set" of cases evaluated by external experts to establish ground truth in the way AI/ML performance studies do. The ground truth for substantial equivalence is based on regulatory standards and the established performance of predicate devices.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable or provided, as there is no mention of a "test set" requiring adjudication by multiple readers/experts.

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

MRMC Study: No. This document concerns a bone grafting material, not an AI/ML-driven diagnostic device that would involve human readers or AI assistance.

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

Standalone Performance Study: No. This is not an AI/ML device.

7. The Type of Ground Truth Used

Ground Truth: For a 510(k) of a bone grafting material, the "ground truth" for demonstrating substantial equivalence often relies on:
- Prior Regulatory Clearances/Approvals: The FDA's previous findings for predicate devices.
- Material Standards: Compliance with recognized standards like ASTM F 1088-04 for Beta-Tricalcium Phosphate.
- Pre-clinical data: (Though not detailed here, often part of the submission) such as in-vitro tests and animal studies demonstrating biocompatibility and osteoconductivity/resorbability.
- Clinical experience: The known performance and safety profile of the class of devices and the specific predicate devices.

The document states, "The effectiveness and safety of the Cerasorb designs compared to the predicate devices" are the basis for substantial equivalence, implying reliance on the established performance of the predicate technologies.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This is not an AI/ML device that uses a "training set."

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

Ground Truth for Training Set: Not applicable. This is not an AI/ML device.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of human figures, possibly symbolizing health and well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 3 2007

Curasan AG, Frankfurt Facility C/O Mr. Eric Weichert President Applications Specialist International, Incorporated 109 Shore Drive Garner, North Carolina 27529

Re: K051443

Trade/Device Name: Cerasorb® Dental, Cerasorb® M Dental, and Cerasorb® Perio Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: May 31, 2005 Received: June 2, 2005

Dear Mr. Weichert:

This letter corrects our substantially equivalent letter of August 3, 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 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 (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.

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.

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Page 2 - Mr. Weichert

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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), please contact the Office of Compliance at (240) 276-0115 (http://www.fda.gov/cdrh/organiz.html#OC for OC organization structure). Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chiu-Liang Ph.D.

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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Cerasorb® M DENTAL

Indications for Use

KOSI443 510(k) Number (if known):

Cerasorb® M DENTAL Device Name:

Indications for Use:

Cerasorb® M DENTAL is recommended for:

Augmentation or reconstructive treatment of the alveolar ridge.
Filling of infrabony periodontal defects.
Filling of miracony person resection, apicoectorny, and cystectorny.
Filling of extraction sockets to enhance preservation of the alveolar ridge.
Elevation of the maxillary sinus floor.
Elevation of periodontal defects in conjunction with products intended for Filling of perfodonali action (GTR) and Guided Bone Regeneration (GBR).
Guided Tissue Regenciation (Oric) and Cattler with products intended for Guided Bone Regeneration (GBR).

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert DDS for Dr. Susan Rumner

(Division Sian-Off Division of Anesthesiology, General Hospital, Infection Control. Dental De

510(k) Number:

Page 1 of 1_

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Statements of Indications for Use 1.4

Cerasorb® DENTAL

Indications for Use

KOS 1443 510(k) Number (if known):

Cerasorb® DENTAL Device Name:

Indications for Use:

Cerasorb® DENTAL is recommended for:

Augmentation or reconstructive treatment of the alveolar ridge. -
Filling of infrabony periodontal defects. ・
Filling of defects after root resection, apicoectomy, and cystectomy. -
Filling of extraction sockets to enhance preservation of the alveolar ridge. -
Elevation of the maxillary sinus floor. -
Filling of periodontal defects in conjunction with products intended for a Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
Gulded I Issue Regenciation (OTT) ... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -Guided Bone Regeneration (GBR).

Prescription Use _

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Page 1 of 1

510(k) Number:_

13 - 6

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Cerasorb® Perio

Indications for Use

KOSIYYZ 510(k) Number (if known):

Cerasorb® Perio Device Name:

Indications for Use:

Cerasorb® Perio is recommended for:

Filling and/or reconstruction of non-infected periodontal bone defects in conjunction with other products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
Filling of infrabony periodontal defects
Filling of single-or multi-wall bone pockets.
Filling of bifurcations and trifurcations

Prescription Use __

. AND/OR

Over-The-Counter Use

(21 CFR 807 Subpart C)

(Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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JUL 2 2 2 2005

Image /page/5/Picture/1 description: The image shows the word "curasan" in a bold, sans-serif font. The letters are black and appear to be slightly distorted, giving them a rounded, almost cartoonish look. The word is presented in a single line, with each letter connected to the next.

K051443

Abbreviated 510 (k) Summary:

Cerasorb® DENTAL Cerasorb® M DENTAL Cerasorb® Perio

SUBMISSION INFORMATION 1.

Name and Address of the Sponsor:	curasan AGLindigstrasse 463801 KleinostheimGermany
Contact person:	Dr. Wolf-Dietrich Huebner, MDMedical DirectorTel.: +49 – 6027 – 4686-325Fax: +49 – 6027 – 4686-433E – Mail: wolf.huebner@curasan.de
Registered U. S. Agent:	Dr. Eric Wiechert, Ph.D.109 Shore DriveGarner, NC 27529, USAPhone: 919 – 772-8518, fax: 919 – 772-1300E – Mail: ewiecher@bellsouth.net

DEVICE IDENTIFICATION 2.

Proprietary Name:	Cerasorb® DENTALCerasorb® M DENTALCerasorb® Perio
Common Name:	Bone Void Filler, Synthetic
Classification Name :	Bone Grafting Material, Synthetic
Classification:	Class II, Special Controls
Classification regulation Number:	21CFR 872.3930
Product Code:	LPK, Tricalcium Phosphate Granules for DentalBone Repair

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PREDICATE DEVICES 3.

Cerasorb® DENTAL: PMA800035 PerioGlas®: K992416, K040278 FENOGILS . RO-OSS® BLOCKS, BIO-OSS® Collagen: K033815 BIO-OSS® Anorganic Bovine Bone: K970321

INTENDED USE 4.

Cerasorb® DENTAL and Cerasorb® M DENTAL are recommended for :

Augmentation or reconstructive treatment of the alveolar ridge -
Filling of infrabony periodontal defects -
Filling of defects after root resection, apicoectomy, and cystectomy. -
Filling of extraction sockets to enhance preservation of the alveolar ridge -
Elevation of the maxillary sinus floor -
Eievaton of the maxmaly since new
Filling of periodontal defects in conjunction with products intended for Guided -Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
Filside Regeneration (Cris) ats in conjunction with products intended for Guided -Bone Regeneration (GBR)

Cerasorb® Perio is recommended for:

Filling and/or reconstruction of non-infected periodontal bone defects in Filling and/or "reconstration" other products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
Filling of infrabony periodontal defects
Filling of single-or multi-wall bone pockets
Filling of bifurcations and trifurcations

DESCRIPTION OF THE DEVICE 5.

Cerasorb® DENTAL, Cerasorb® M DENTAL and Cerasorb® Perio are a sterile, Cerasorb DENTRE, Ceramic matrix in either granilar form (Cerasorb Syntifetic, polygonal shaped morsels (Cerasorb M DENTAL) or polygonal broken DENTAL), polygonal "shaped" morbols" (Soint of pure-phase Beta-Tricalcium Phosphate grandlate (Crasorb Ferro). This access. ply with the ASTM F 1088-04. The devices, when with a phase purry of - 9778 and compy make of large, smoothly intercomected pores applied to a bony defect, ereate a rto DENTAL approx. 35%, Cerasorb M DENTAL providing anterent porosity] and Cerasorb Perio approx. 25vol%).

approx. 05 v0170 [total porochy] and ored by a validated manufacturing process which The different designs are managed and reproducibility. Due to their synthetic nature guarantees battli to batch conformily and repredactions and are neither locally nor systemically toxic.

Iocally not systembally toxic.
In contact with vital bone the Cerasorb granules, morsels or granulate is resorbed and gradually replaced by new bone.

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Cerasorb DENTAL, Cerasorb M DENTAL and Cerasorb Perio are provided in double Cerason DENTAL, Cetasons in gamma irradiation) and are for single-use only.

BASIS FOR SUBSTANTIAL EQUIVALENCE 6.

Cerasorb DENTAL, Cerasorb M DENTAL and Cerasorb Perio are substantially Celasolo DENTAL; Colusion -11- narketed and approved/cleared bone void fillers for defects in the oral/maxillofacial and dental region, such as Cerasorb DENTAL (the sponsors own device formally regulated as a PMA, PMA800035), BIO-OSS® Anorganic sponsors own device formally regulated as a Flass (K992416, K040278).

Bovine Dolle (1376521, 1635013) and ifferent (Beta-Tricalcium Phosphate vs. Bovine Although the source of the material), the intended use, recommended indications Bone vs. synthette blouerry glass material site, and performance data fr the three Cerasorb for use, and the predicate devices are essentially similar. Also, all materials are designs and biocompatible. In contact with vital bone any of the bone grafting materials is resorbed and gradually replaced by new bone.

materials is resorded and gradually replasse of nones the effectiveness and safety of the Cerasorb designs compared to the predicate devices.

STATEMENT OF TECHNOLOGICAL COMPARISON 7.

All Cerasorb design modifications consist of pure phase Beta-Tricalcium Phosphate All Cerason design modified on the 1088-04. The material is of intercomnecting porosity, osteoconductive and resorbable.

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.