ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE

K051381 · Ace Surgical Supply Co., Inc. · LYC · Jul 15, 2005 · Dental

Device Facts

• Record ID: K051381
• Device Name: ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE
• Applicant: Ace Surgical Supply Co., Inc.
• Product Code: LYC · Dental
• Decision Date: Jul 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ACE SurgicalPlaster Calcium Sulfate Hemihydrate is intended to be used by itself in bone regenerative techniques; mixed with other suitable bone filling agents to prevent particle migration in an osseous defect, and, to provide a resorbable barrier over other bone graft material.

Device Story

ACE SurgicalPlaster Calcium Sulfate Hemihydrate is a medical-grade calcium sulfate hemihydrate bone void filler. It is supplied as a powder, mixed with sterile saline to form a putty-like paste, and applied to osseous defects by a clinician. The material sets in vivo; it acts as a scaffold for bone in-growth while gradually dissolving and resorbing. It serves as a standalone regenerative material or as a barrier to prevent particle migration of other graft materials. Used in dental/surgical settings to facilitate bone repair.

Clinical Evidence

No clinical data provided; substantial equivalence is based on device description, intended use, and material characteristics.

Technological Characteristics

Medical grade calcium sulfate hemihydrate. Supplied as powder for mixing with sterile saline to form a putty. Sets in vivo. Resorbable. Standalone device.

Indications for Use

Indicated for use in bone regenerative techniques, either alone or mixed with other bone filling agents to prevent particle migration in osseous defects, and as a resorbable barrier over other bone graft materials.

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

• Orthogen SurgiPlaster Calcium Sulfate Hemihydrate (K011403)

Submission Summary (Full Text)

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## Additional Requested Information, K051381

510(k) Notification, Amended Submission ACE SurgicalPlaster Calcium Sulfate Hemihydrate ACE Surgical Supply Co., Inc. 1034 Pearl Street Brockton, MA 02301

### Attachment 3 - 510(k) Summary

JUL 1 5 2005

Submitter Name: Submitter Address : Contact Person: Phone Number: Fax Number: Date Prepared: Device Trade Name: Device Common Name: Classification Name: Predicate device: Reason for submission:

ACE Surgical Supply Co., Inc. 1034 Pearl St., Brockton, MA 02301 J. Edward Carchidi, DDS [phone] [phone] May 2005 ACE SurgicalPlaster Calcium Sulfate Hemihydrate Calcium Sulfate Hemihydrate Bone Filling Augmentation Material, unclassified Orthogen Surgiplaster Calcium Sulfate Hemihydrate, K011403 Not previously marketed in the USA

#### Device Description and Materials:

Device Desomption and Macena. Culfate Hemilydrate is a medical grade calcium sulfare heminydrate The ACE Surgical laster Odliato Homals Homenato is a models of the nitended to be used by itself in bone regenerative techniques.

The ACE SurgicalPlaster Calcium Sulfate Hemihydrate is designed to set-up in vivo. It is mixed with small The AOL Gurgicul Tactor Schution to produce a putty-like paste and it is applied on bone defects in announts of regular sciling soldion to production in production in stellier of stellier of the last over may be set using a small square of sterile gauze soaked in the fast setting solution. With time, the layer may be on acting a calcium Sulfate Hemilydrate dissolves and recedes leaving behind resorbing, so. AOL Surgicall factor outlate of that have been found to stimulate bone in-growth.

#### Intended Use:

Intended USE.
The ACE SurgicalPlaster Calcium Sulfate Hemihydrate is intended to be used by itself in bone regenerative The ACE Surgicall laster Oaliate Home Homan Station Marticle migration in an osseous defect, and, to provide a resorbable barrier over other bone graft material..

## Substantial Equivalence/ Device Technological Characteristics

and Comparison to Predicate Device(s):

and Companison to Precious Borres(e);
The ACE SurgicalPlaster Calcium Sulfate Hemihydrate is substantially equivalent to the Orthogen SurgiPlaster™ Calcium Sulfate Hemihydrate, K011403.

Among the information and data presented in the 510(k) submission to support the substantial equivalency Among the Miorination and data presented in the origins damicate device are 1) device are: 1) device of the ACE Surgical Flaster Oalerials, and 4) labeling. In particular, the information demonstrated description, a) indications for asc, of materials, and 1) ias civing ess between the ACE SurgicalPlaster Calcium Sulfate Hemihydrate and the specified predicate device.

A3-1A

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, with three wavy lines forming the body and head. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 1 5 2005

J. Edward Carchidi, DDS President ACE Surgical Supply Company, Incorporated 1034 Pearl Street Brockton, Massachusetts 02301

Re: K051381

Trade/Device Name: ACE SurgicalPlaster Calicum Sulfate Hemihydrate Regulation Number: 21 CFR 872.3930 Regulation Name: Tricalcium Phosphate Granules for Dental Bone Repair Regulatory Class: II Product Code: LYC Dated: July 5, 2005 Received: July 6, 2005

Dear Dr. Carchidi:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becater by on 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 Interstate commerce prior sthat have been reclassified in accordance with the provisions of Alliendinents, of to devroes that not in the Act (Act) that do not require approval of a premarket the Federal I od; Drug, und Common , therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of ar 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 such additional controls. Existing major regulations affecting (1 Mr), it may of bund in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear be routlish further announcements concerning your device in the Federal Register.

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#### Page 2 - Dr. Carchidi

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that IDA s issuance of a basetant is with other requirements
mean that FDA has made a determination that your device Federal accepares mean that FDA has made a decommance in administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by other its increasing in of the Act of any rederal statutes and regulations, but not-limited to: registration You must colliply with an the Act 3 requirement 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gEP Bart 800); and i and listing (21 CFR I art 607), lacems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality byochine (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin mailioning your device of your device to a premarket notification. The PDA midness of baseasines of the results 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), a If you desire specific auvice for your do records on a more a more and the regulation please contact unc Other or Ochiphanes and =================================================================================================================================== may obtain other general information on your responsibilities under the Act from the may obtain other general mionmation on the motional and Consumer Assistance at its toll-free DIVIsion of Sinall 2011 or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Suite Y. Michael Oms
Shilin, PhD

Chiú 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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Additional Requested Information, K051381 Auditional Request, Amended Submission 510(K) Nottfication, Finisher
ACE SurgicalPlaster Calcium Sulfate Hemihydrate ACE Surgical Supply Co., Inc. 1034 Pearl Street Brockton, MA 02301

# Indications for Use

510(k) Number (if known):__K051381____________________________________________________________________________________________________________________________________________

ACE SurgicalPlaster Calcium Sulfate Hemihydrate Device Name: مخترحيثـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ

Indications for Use:

The ACE SurgicalPlaster Calcium Sulfate Hemihydrate is intended to be used by
the filling The ACE SurgicalPraster Calcium Outlate Homith ather suitable bone filling
itself in bone regenerative techniques; mixed with other suitable a itself in bone regenerative techniques, mixed will and to provide a
agents to prevent particle migration in an osseous defect, and, to provide a
ministration prevent particle agents to prevent partier over other bone graft material.

AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

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)

R.S.Betz MS for Dr. S. Runner

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

510(k) Numbe