-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)
-Filling of perio-implant defects 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 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® CLASSIC, CERASORB® M and CERASORB® Perio are a sterile, synthetic, porous and biocompatible ceramic matrix in either granular form (CERASORB® CLASSIC), polygonal shaped morsels (CERASORB® M) or polygonal broken granulate (CERASORB® Perio). All designs consist of pure-phase Beta-Tricalcium Phosphate with a phase purity of ≥ 99% and comply with the ASTM F 1088-04. The devices, when applied to a bony defect, create a network of large, smoothly interconnected pores providing different porosities (CERASORB® CLASSIC approx, 35%, CERASORB® M approx. 65 vol% [total porosity] and CERASORB® Perio approx. 25vol%).

The different designs are manufactured by a validated manufacturing process which guarantees batch to batch conformity and reproducibility.

In contact with vital bone the CERASORB® granules, morsels or granulate is resorbed and gradually replaced by new bone.

CERASORB® CLASSIC, CERASORB® M and CERASORB® Perio are provided in double sterile packages (sterilization via gamma irradiation) and are for single-use only.

AI/ML Overview

The provided 510(k) summary for K113282 (CERASORB® CLASSIC, CERASORB® M, CERASORB® Perio) is a "Special 510(k) Summary," which typically signifies a change to an already cleared device, not an initial submission requiring extensive clinical or performance studies for effectiveness. In this specific case, the basis for substantial equivalence explicitly states:

"CERASORB® CLASSIC, CERASORB® M and CERASORB® Perio differ from the products of the same name cleared by K051443 only in the information on the labeling designating the manufacturer. Riemser AG is now both the manufacturer and distributor of the CERASORB® products described in the present 510(k) document."

Therefore, the submission relies on the prior clearance (K051443) and does not present new performance data or studies to demonstrate the device meets acceptance criteria. The acceptance criterion is, by extension, that the device is identical in all material aspects (except manufacturer details on labeling) to the previously cleared predicate device.

Given this, most of the requested information about acceptance criteria and studies (test set, ground truth, expert adjudication, MRMC studies, standalone performance, training set) would not be applicable to this specific Special 510(k) submission.

Here's a breakdown based on the provided document:

A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The device must be materially identical (composition, physical properties, intended use) to the predicate devices cleared under K051443. The primary change is the manufacturer/distributor details on the labeling.
- Reported Device Performance: Not applicable for a Special 510(k) where the only change is manufacturing/labeling parties. The performance is implicitly considered to be the same as the predicate device (CERASORB® DENTAL, CERASORB® M DENTAL, CERASORB® Perio under K051443).
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No new test set or data provenance is provided in this Special 510(k) as no new studies were conducted. The submission leverages the prior clearance.
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)
- Not applicable. No new ground truth establishment was required for this type of submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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
- Not applicable. This device is a bone void filler, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a bone void filler, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for this Special 510(k). The original predicate device's clearance (K051443) would have established biocompatibility, material properties, and potentially clinical effectiveness through various means, but those details are not in this submission.
The sample size for the training set
- Not applicable.
How the ground truth for the training set was established
- Not applicable.

In summary, this Special 510(k) does not present new studies; rather, it asserts substantial equivalence based on the device being identical to its cleared predicate except for manufacturing/labeling details. Therefore, the "acceptance criteria" and "study" are effectively the prior 510(k) clearance (K051443) and the documentation proving that the current device is the same as the predicate.

Summary

{0}------------------------------------------------

K113282

510(k) Summary

Section 05 Erst

Arzneimittel AG

Special 510 (k) Summary: CERASORB® CLASSIC CERASORB® M CERASORB® Perio

SEP
2 0 2012

Date prepared: September 17, 2012

l. SUBMISSION INFORMATION

Name and Addressof the Sponsor:	Riemser Arzneimittel AGAn der Wick 7Greifswald-Insel RiemsMecklenburg-Vorpommern 17493, Germany
Contact person:	Dr. Andreas PüttnerHead of Regulatory AffairsTel.: +49-3835-1760Fax: +49-3835-176778E - Mail: dr.puettner@riemser.de
Registered U. S. Agent:	James M. ClintonQuality & Regulatory Consulting, LLC5105 Fairoaks RdDurham, NC 27712, USAPhone: +1919-247-0479, fax: +1919-287-2551E - Mail: clintonjm@earthlink.net
2. DEVICE IDENTIFICATION
Proprietary Name:	CERASORB® CLASSICCERASORB® MCERASORB® 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: LYC

{1}------------------------------------------------

510(k) Summary

Section 05

3. PREDICATE DEVICES

CERASORB® DENTAL: K051443 CERASORB® M DENTAL: K051443 CERASORB® Perio: K051443

4. INTENDED USE

CERASORB® CLASSIC and CERASORB® M 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

-Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)

-Filling of perio-implant defects 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 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

DESCRIPTION OF THE DEVICE 5.

The different designs are manufactured by a validated manufacturing process which guarantees batch to batch conformity and reproducibility.

In contact with vital bone the CERASORB® granules, morsels or granulate is resorbed and gradually replaced by new bone.

{2}------------------------------------------------

CERASORB ®	Section 05
510(k) Summary	RIEMSER Arzneimittel AG

CERASORB® CLASSIC, CERASORB® M and CERASORB® Perio are provided in double sterile packages (sterilization via gamma irradiation) and are for single-use only.

BASIS FOR SUBSTANTIAL EQUIVALENCE 6.

CERASORB® CLASSIC, CERASORB® M and CERASORB® Perio differ from the products of the same name cleared by K051443 only in the information on the labeling designating the manufacturer. Riemser AG is now both the manufacturer and distributor of the CERASORB® products described in the present 510(k) document.

STATEMENT OF TECHNOLOGICAL COMPARISON 7.

The CERASORB® CLASSIC, CERASORB® M, and CERASORB® Perio devices are substantially equivalent to the respective devices cleared by K051443: CERASORB® DENTAL, CERASORB® M Dental, and CERASORB® Perio.

5 - 3

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's name encircling a stylized eagle emblem. The eagle is depicted with three overlapping, curved lines forming its body and wings, conveying a sense of motion and progress. The overall design is simple, yet recognizable, representing the department's role in public health and human services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SEP 2 0 2012

Riemser Arzneimittel AG C/O Mr. James M. Clinton Quality & Regulatory Consulting, Limited Liability Company 5105 Fairoaks Road Durham, North Carolina 27712

Re: K113282

Trade/Device Name: Cerasorb® Classic Cerasorb® M Cerasorb® Perio Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: August 17, 2012 Received: August 21, 2012

Dear Mr. Clinton:

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.

{4}------------------------------------------------

Page 2- Mr. Clinton

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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

{5}------------------------------------------------

Indications for Use

Page 1 of l

Page 1 of __

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Kummer

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesion Devices Division of Anest. Dental Devices

510(k) Number: K113252

4 - 1

Indications for Use

KI13282 510(k) Number (if known):

Cerasorb® CLASSIC Device Name:

Indications for Use:

Cerasorb® CLASSIC is recommended for:

Augmentation or reconstructive treatment of the alveolar ridge. -
ー 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).
Filling of perio-implant defects in conjunction with products intended for Guided -Bone Regeneration (GBR).

Prescription Use (Part 21 CFR 801 Subpart D)

IF NEEDED)

AND/OR

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

Over-The-Counter Use (21 CFR 807 Subpart C)

Section 04

(k) Number (if known): K 1 328

Cerasorb® CLASSIC

{6}------------------------------------------------

CERASORB®
-----------

Indications for Use

510(k) Number (if known):

Cerasorb® M Device Name:

Indications for Use:

Cerasorb® M 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).
Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

Prescription Use (Part 21 CFR 801 Subpart D)

:: '' '

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

Section 04

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Page 1 of
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number:	K113282

4 - 2

{7}------------------------------------------------

Indications for Use

Image /page/7/Picture/2 description: The image shows the text "K113282" at the top, followed by "Section 04" in bold. The text "Section 04" is centered and has a line above it. Below that is a logo that is difficult to make out.

A. 2022年12月16日

Indications for Use

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 > (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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 Sian-Off) Division of Anesthesiology, General Hosanal Infection Control, Dental Devices

Page 1 of

510(k) Number: K152858

4 - 3

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.