(90 days)
Sulzer Calcitek Dental Implant Systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement. The use of the 5.0mm implant is recommended when the quantity and density of bone would dictate the use of an implant larger than 4.0mm.
Spline XI implants are available both with and without HA-coating. They are available in 3.75mm or 5.0mm diameters and are available in five lengths: 8, 10, 13, 15 and 18mm. A total of four surface styles are available: HA-coated, HAcoated/textured, HA-coated/machined and textured/machined. The implants are supplied sterile.
The provided document is a 510(k) summary for the Sulzer Calcitek Spline Dental Implant System - Spline XI. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel study to prove the device meets specific acceptance criteria in the way a new medical algorithm's performance would be assessed.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to this type of submission.
Instead, the document's primary purpose is to compare the new device (Spline XI) to an existing, legally marketed predicate device (Sulzer Calcitek's existing Spline Dental Implant System) based on technological characteristics and intended use. The acceptance criteria are implicitly met if the device can demonstrate substantial equivalence to the predicate.
Here's an analysis of the provided information within the context of a 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the traditional sense for a 510(k) summary focused on substantial equivalence. The "acceptance criteria" are demonstrating that the new device shares fundamental technological characteristics and intended use with the predicate device, and that any differences do not raise new questions of safety and effectiveness.
The document provides a comparison table (Section 4) of features:
| Feature | Spline XI implant | Predicate Implants |
|---|---|---|
| Implant body geometry | screw type endosseousimplants | screw type endosseousimplants |
| Implant lengths | 8, 10, 13, 15, 18mm | 8, 10, 13, 15, 18mm |
| Implant diameters | 3.75, 5.0mm | 3.75, 5.0mm |
| Implant body material | Titanium alloy | Titanium alloy |
| Implant/abutmentinterface | spline - 6 tines | spline - 6 tines |
| Manufacturing site | Carlsbad, CA | Carlsbad, CA |
| HA Coating | Available on some designs | Available on some designs |
| Sterile | Yes | Yes |
The reported "performance" is that the overall design of the Spline XI implants are identical to the predicate implants in these key characteristics, with a single modification: "There has been a modification to the apical portion of the implant body to provide the implant with self-tapping capabilities." The submission implicitly argues that this modification does not alter the fundamental safety or effectiveness.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is not a performance study on a test set of data. The "test set" in a sense is the predicate device itself, against which the new device is compared. The data provenance is the design and manufacturing specifications of both the Spline XI and the predicate Spline Dental Implant System.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable for this type of submission. The "ground truth" for substantial equivalence is based on regulatory standards and the established safety and effectiveness profile of the predicate device. The information provided in the Class III Summary (Sections 3 and 4) cites scientific literature and FDA guidance regarding potential complications associated with dental implants generally, which serves as a background for evaluating the safety of the device type.
4. Adjudication Method for the Test Set
Not applicable. There is no adjudication of a test set in the context of this 510(k) 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
Not applicable. This device is a dental implant, not an AI-assisted diagnostic or therapeutic tool for which an MRMC study would be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is derived from:
- Regulatory definitions and established predicates: The FDA's classification of dental implants and the legal marketing status of the predicate device.
- Scientific and clinical literature: The Class III Summary (Sections 3 and 4) provides a detailed list of reported adverse safety and effectiveness information for endosseous dental implants, along with possible causes and citations to peer-reviewed journals and FDA documents (e.g., Federal Register). This serves as a comprehensive understanding of potential risks associated with this device type.
- Company documents and customer feedback: Mentioned in the Class III Certification as sources for understanding safety and effectiveness information, including specific issues like dental bur fracture, mal-positioned implants, and psychological rejection of implants (Section 4).
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning or complex algorithm development.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the reasons stated above.
In summary, the provided document is a regulatory submission for a physical medical device, not a study evaluating an AI algorithm. The "acceptance criteria" and "study" described are fundamentally different, focusing on demonstrating equivalence to an existing device through a comparison of design, materials, and intended use, rather than a performance evaluation against a defined ground truth using statistical metrics.
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JUL 30 1998
510(K) SUMMARY
Pursuant to 513(i) of the Federal Food, Drug, and Cosmetic Act, as Amended.
| Company Name: | Sulzer Calcitek Inc. |
|---|---|
| Address: | 2320 Faraday Avenue, Carlsbad, CA 92008 |
| Telephone Number: | (760) 431-9515 |
| Registration Number: | 2023141 |
| Contact Person: | Foster Boop |
| Date Summary Prepared: | April 30, 1998 |
| Classification Name: | Implant, Endosseous (76DZE) |
| Common/Usual Name: | Dental Implant System |
| Device Trade Name: | Spline Dental Implant System - Spline XI |
The primary device used for comparison purposes in this summary is Sulzer Calcitek's existing Spline Dental Implant System: HA-coated implants and uncoated textured self-tapping threaded implants. All implant systems are manufactured in the i same facility located in Carlsbad, California.
The statements of intended use are identical. 1. Intended Use:
Calcitek Dental Implant Systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement. The use of the 5.0mm implant is recommended when the quantity and density of bone would dictate the use of an implant larger than 4.0mm.
2. Description:
Spline XI implants are available both with and without HA-coating. They are available in 3.75mm or 5.0mm diameters and are available in five lengths: 8, 10, 13, 15 and 18mm. A total of four surface styles are available: HA-coated, HAcoated/textured, HA-coated/machined and textured/machined. The implants are supplied sterile.
3. Technological Characteristics:
There has been a modification to the apical portion of the implant body to provide the implant with self-tapping capabilities. The implant/abutment interface remains unchanged. There has been no change to the materials of this device or to the implant/abutment interface.
510(k) Summary Page 1 of 2
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4. Comparison Analysis:
1
ﺷﻴﺮ ﺍﻟﻤﺴﺘﺸﻴﺮ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ
The overall design of the Spline XI implants are identical to the predicate implants.
| Feature | Spline XI implant | Predicate Implants |
|---|---|---|
| Implant body geometry | screw type endosseousimplants | screw type endosseousimplants |
| Implant lengths | 8, 10, 13, 15, 18mm | 8, 10, 13, 15, 18mm |
| Implant diameters | 3.75, 5.0mm | 3.75, 5.0mm |
| Implant body material | Titanium alloy | Titanium alloy |
| Implant/abutmentinterface | spline - 6 tines | spline - 6 tines |
| Manufacturing site | Carlsbad, CA | Carlsbad, CA |
| HA Coating | Available on some designs | Available on some designs |
| Sterile, | Yes | Yes |
... ... ...
510(k) Summary Page 2 of 2
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Spline Dental Implant System - Spline XI
- For submissions claiming substantial equivalence to a device which has been (i) classified into class III under section 513(b) of the act:
- (1) Which was introduced or delivered for introduction into interstate commerce for commercial distribution before December 1, 1990: and
- (2) For which no final regulation requiring premarket approval has been issued under section 515(b) of the act, a summary of the types of safety and effectiveness problems associated with the type of devices being compared and a citation to the information upon which the summary is based (Class III Summary). The 510(k) submitter shall also certify that a reasonable search of all information known or otherwise available about the class III device and other similar legally marketed devices has been conducted (Class III Certification), as described in Sec. 807.94.
A Class III Certification and Summary is provided on the following pages.
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PREMARKET NOTIFICATION CLASS III CERTIFICATION AND SUMMARY
(As Required by 21 CFR 807.94)
I certify, in my capacity as Regulatory Affairs Associate, of Sulzer Calcitek Inc, that I have conducted a reasonable search of all information known or otherwise available about the types and causes of safety or effectiveness problems that have been reported for the endosseous dental implant. I further certify that I am aware of the types of problems to which the endosseous dental implant is susceptible and that, to the best of my knowledge, the following summary of the types and causes of safety or effectiveness problems about the endosseous dental implant is complete and accurate. Such search is defined as examining:
- the FDA proposal to require the filing of premarket approval applications (PMAs) for endosseous dental implants, section D, "Degree of Risk," (Federal Register, Vol. 54, No. 234, 12/7/89, p. 50593).
- article titles and abstracts for the citations found when using search strategy for items which include dental implant(s) or endosseous, and fail?, complicat?, risk? hazard?, safety, effectiveness, side effect? adverse? problem? or success rate? using Medline database, 1989-present, accessed using PubMed at http:\ www.ncbi.nlm.nih.gov in March 1998.
- relevant company documents, including product labeling, concerning the safety and effectiveness information of endosseous implants.
Attached to this certification is a summary of and citation to the adverse safety and effectiveness data found in that search.
Name of individual signing the certification: Foster Boop
April 30, 1998
Signature: Title:
TustunBove
Regulatory Affairs Associate
Company Name: Address: Phone Number:
Sulzer Calcitek Inc. 2320 Faraday Avenue, Carlsbad, California 92008 (760) 431-9515
Date:
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Spline Dental Implant System – Spline XI
:
ಕಾರಿ ಮಾತ್ರವ
| SUMMARY OF POSSIBLE COMPLICATIONS ASSOCIATEDWITH DENTAL IMPLANTS | |||
|---|---|---|---|
| Reported Adverse S&EInformation | Possible Causes | Citation | |
| Local soft tissue degeneration | 1) gingivitis2) infection | · Federal Register (FR), 54 (234),12/7/89, p. 50593.· Int J Oral Maxillofac Implants,Winter 1992, 7 (4), p. 477-84. | |
| Bone resorption | 1) infection (see below)2) poor oral hygiene3) mal-distribution of occlusalforces:a) poorly designed prosthetics(nonpassive fit, which maycause micro-movement, tensionon the implants, and/orprosthetic loosening, overload,etc.)b) traumatic occlusal forces4) inadequate bone at the time ofplacement5) bone necrosis due toinadequate cooling duringdrilling | · Federal Register (FR), 54 (234),12/7/89, p. 50593.· Dent Clin North Am, Jan 1992,36 (1), p. 27-37.· J Osaka Univ Dent Sch, Dec1990, 30, p. 86-96.· Quintessence Int, Dec 1992, 23(12), p. 811-6.· J Prosthet Dent, Aug 1993, 70(2), p. 135-40.· Curr Opin Periodontol, 1994, p.194-204.· Int J Oral Maxillofac Implants,V10 N3, 1995, pp. 373-8.· Int J oral Maxillofac Implants,V10 N3, 1995 May-Jun, pp. 303-11.· Biomaterials, Aug 1995, 16(2),917-20 | |
| Perforation of the maxillarysinus/oroantral fistula/oronasalfistula | 1) poor bone quality2) inadequate bone quantity ormisjudgment of available bone3) improper drill lengthselection | · Federal Register (FR), 54 (234),12/7/89. p. 50593.· Dtsch Zahnarztl Z (Germany),Jan 1990, 45 (1), p. 58-60· AORN J, Mar 1990, 51 (3), p.729, 731, 733-4 passim.· J Oral Maxillofac Surg, Nov1993, 5 (11), p. 1198-203. | |
| Perforation of the labial andlingual plates | 1) poor bone quality2) inadequate ridge width3) improper placement/alignment of device | · Federal Register (FR), 54 (234),12/7/89. p. 50593. | |
| SUMMARY OF POSSIBLE COMPLICATIONS ASSOCIATEDWITH DENTAL IMPLANTS | |||
| Reported Adverse S&EInformation | Possible Causes | Citation | |
| Paresthesia/nerve injury | 1) improper placement of devicecausing impingement of thenerve2) poor bone quality allowingaccidental displacement into themandibular canal3) repositioning of the nerve forplacement of the device4) damage to the nerve duringdrilling of site | · Federal Register (FR), 54 (234),12/7/89. p. 50593.· Int J Oral Maxillofac Implants,Fall 1991, 6 (3), p. 264-9.· Oral Surg Oral Med OralPathol, Jul 1990, 70 (1), p. 24-8.· Ohio Dent J, Spring-Summer1992, 66 (1), p. 16-7, 19-25.· J Prosthet Dent, Oct 1992, 68(4), p. 664-71.· Int J Oral Maxillofac Implants,Spring 1992, 7 (1), p. 45-50.· Int J Oral Maxillofac Implants,Mar-Apr 1994, 9 (2), p. 249-54.· J Oral Maxillofac Surg, V53N3, 1995 Mar, pp. 264-8.· J Prosthetic Dent Dec 1997,78(6), p. 537-41 | |
| Exfoliation (post-restoration) | (See bone resorption risk above)1) infection (see below)2) poor oral hygiene3) mal-distribution of occlusalforces:a) poorly designed prosthetics(nonpassive fit, which maycause micro-movement, tensionon the implants, and/orprosthetic loosening, overload,etc.)b) traumatic occlusal forces4) inadequate bone at the time ofplacement5) bone necrosis due toinadequate cooling duringdrilling | · Federal Register (FR), 54 (234),12/7/89. p. 50593.· J Prosthet Dent, Feb 1992, 67(2), p. 236-45.· J Parodontol, May 1991, 10 (2),p. 219-25.· Pract Periodontics AesthetDent, Aug 1993, 5 (6), p. 11-20.· Int J Oral Maxillofac Implants,1993, 8 (1), p. 92-7.· Int J Oral Maxillofac Implants,V10 N1, 1995 Jan-Feb, pp. 33-42.· Biomaterials V16 N12, Aug1995, pp. 917-920.· J Oral Maxillofac Surg, V52N9, PP. 937-43.· Int J Oral Maxillofac Implants,Jan-Feb 1995, V10 N1, pp. 74-8,89-98. | |
| SUMMARY OF POSSIBLE COMPLICATIONS ASSOCIATEDWITH DENTAL IMPLANTS | |||
| Reported Adverse S&EInformation | Possible Causes | Citation | |
| Local and systemic infection | 1) poor oral hygiene2) contaminated surgical field3) device not sterile | • Federal Register (FR), 54 (234),12/7/89. p. 50593.• Clin Oral Implants Res, Dec1992, 3 (4), p. 162-8.• J Oral Implantol, 1993, 19 (4),p. 321-35.• J Periodontol V66 N1, 1995Jan, pp. 69-74.• Int J Oral Maxillofac ImplantsV9 N2, 1994 mar-Apr, pp. 197-206.• Head Neck, Mar-Apr 1996, 18(2), p. 192-6.• Int J Oral Maxillofac Implants,Mar-Apr 1996, 11(2), P. 205-9. | |
| Maxillary sinusitis | perforation of the maxillarysinus | • J Oral Maxillofac Surg, Mar1992, 50 (3), p. 285-7.• J Oral Implantol, 1992, 18 (1),p. 15-23.• J Laryngol Otol, Apr 1990104(4), p. 333-4 | |
| Implant fracture | 1) inadequate structural strength2) inadequate bony support:a) insufficient bone atplacementb) bone resorption | • Federal Register (FR), 54 (234),12/7/89. p. 50593.• Int J Oral Maxillofac Implants,Fall 1989, 4 (3), p. 255-6.• Int J Oral Maxillofac Implants,1993, 8 (4), p. 409-14.• Int J Oral Maxillofac ImplantsV10 N3, 1995 May-Jun, pp. 326-34.• Clin Oral Implants Res V5 N1,1994 Mar, pp. 9-18. | |
| Dental bur fracture | 1) inadequate structural strength2) improper use, including notdrilling in an up-and-downmotion | • Sulzer Calcitek customerfeedback | |
| SUMMARY OF POSSIBLE COMPLICATIONS ASSOCIATEDWITH DENTAL IMPLANTS | |||
| Reported Adverse S&EInformation | Possible Causes | Citation | |
| Abutment fracture | 1) inadequate structural strength2) inadequate bony support:a) insufficient bone atplacementb) bone resorption3) poorly designed prosthesis4) traumatic or destructiveocclusal forces | · Federal Register (FR), 54 (234),12/7/89. p. 50593.· J Prosthet Dent, Jul 1992, 68(1), p. 93-5.· J Oral Rehabil, Jul 1993, 20 (4),p. 413-22. | |
| Hemorrhage | lacerations or transections of thefacial and/or lingual arteries inthe floor of the mouth duringdrilling | · J Am Dent Assoc., Nov 1990,121 (5), p. 599-60.· J Oral Maxillofac Surg, Feb1990, 48 (2), p. 201-4.· J Am Dent Assoc., Jan 1991,122 (1), p. 22-4, 26-8.· Int J Oral Maxillofac Implants,1993, 8 (3), p. 329-34. | |
| Mandibular fracture | 1) inadequate bone width2) poor bone quality | · J Oral Maxillofac Surg, Mar1990, 48 (3), p. 311-7.· Int J Oral Maxillofac Implants,Fall 1991, 6 (3), p. 264-9.· Acta Stomatol Belg V90 N4,1993 Dec. pp. 251-8. | |
| Air embolism5 | introduction of compressedcoolant air via a surgical bur | · Can J Anaesth, Jan 1990, 37(1), p. 112-21.· Int J Oral Implantol, 1989, 6(1), p. 50-63.· J Periodontol, Jan 1992, 63 (1),p. 63.· Chest, Feb 1992, 101 (2), p.561-2.· J Oral Rehabil V21 N6, 1994Nov, pp. 721-2. | |
| SUMMARY OF POSSIBLE COMPLICATIONS ASSOCIATEDWITH DENTAL IMPLANTS | |||
| Reported Adverse S&EInformation | Possible Causes | Citation | |
| Subcutaneous emphysema | introduction of air via cleaninginstrument | Rev Belge Med Dent, 1991, 46(3), p. 64-71. | |
| Injury to adjacent teeth andsupporting structures | 1) damage to tooth root orsurgical trauma during drillingor placement2) poor prosthetic design3) traumatic occlusion | • AORN J, Mar 1990, 51 (3), p.729, 731, 733-4 passim.• Int J Oral Maxillofac Implants,Fall 1991, 6 (3), p. 270-6.• Int J Prosthodont, Jan-Feb1990, 3 (1), p. 89-92.• J Dent, Aug 1993, 21 (4), p.203-8. | |
| Gingivitis | poor oral hygiene | • Ned Tijdschr Tandheelkd. Aug1990, 97 (8), p. 327-31.• Shigaku, Oct 1989, 77 (SPEC)p. 1235-45.• J Prosthet Dent V72 N2, 1994Aug, pp. 144-51. | |
| Hyperplasiaformation/granuloma | 1) exuberant healing process2) poor oral hygiene | • Int J Oral Maxillofac Implants,Summer 1991, 6 (2), p. 215-7.• Shigaku, Oct 1989, 77 (SPEC)p. 1235-45.• Clin Oral Implants Res, Dec1992, 3 (4), p. 149-61.• Implant Dent, Spring 1993, 2(1), p. 27-30. | |
| Delayed healing/ failure tointegrate (exfoliation prior torestoration) | 1) poor bone quality or otherpatient factors (e.g., systemicdisease, excessivetobacco/alcohol use, etc.)2) healing not passive3) site not properly prepared4) inadequate bone at the time ofimplant placement5) bone necrosis due toinadequate cooling duringdrilling6) infection | • Int J Oral Maxillofac Implants,Fall 1990, 5 (3), p. 272-81.• J Periodontol, Apr 1993, 64 (4),P. 306-10.• Int J Oral Maxillofac Implants,1993, 8 (1), p. 92-7.• Calcitek product labeling• J Prosthet Dent V71 N4, 1994Apr, pp. 375-8.• J Endo (United States), Mar1996, 22 (3), p. 135-9. | |
| SUMMARY OF POSSIBLE COMPLICATIONS ASSOCIATEDWITH DENTAL IMPLANTS | |||
| Reported Adverse S&EInformation | Possible Causes | Citation | |
| Hyperesthesia/Hypoesthesia | 1) improper placement of deviceinvolving impingement of thenerve2) repositioning of the nerve fordevice placement3) damage to the nerve duringdrilling4) poor bone quality allowingaccidental displacement into themandibular canal | · Sulzer Calcitek product labeling | |
| Laryngeal obstruction,pneumothorax | screwdriver (tool) aspiration | · Int J Oral Maxillofac Surg, Dec1992, 21 (6), p. 339-41· Int J Oral Maxillofac Surg, Sept1996, 11 (5), p. 679-81. | |
| Edema, hematoma | possible surgical side effects | · Sulzer Calcitek product labeling | |
| Mal-positioned implants | 1) poor bone quality allowingaccidental displacement2) insufficient bone quantity | · Sulzer Calcitek customerfeedback· J Prosthet Dent V71 N4, 1994Apr, pp. 359-63.· J Oral Maxillofac Surg V52 N9,1994 Sep, pp. 937-43.· Int J Oral Maxillofac Implants,Jul-Aug 1995, V10 N4, pp. 485-90. | |
| Psychological rejection ofimplants | poor patient screening | · Sulzer Calcitek customerfeedback | |
| Local and generalized allergicreaction 6 | hypersensitivity | · Sulzer Calcitek product labeling |
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5 Investigation supported the hypothesis that air was introduced via the dental burs due to use of compressed coolant air driven systems. The College of Dental Surgeons of British Columbia has recommended to its members involved in the placement of implants that they review their technique to ensure that compressed air is not introduced into the surgical site via a surgical bur. A similar recommendation is included in the instructions for use of this product.
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6 No reports of allergic reaction have been received to date.
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Image /page/10/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 0 1998
Mr. Foster Boop Requlatory Affairs Associate Sulzer Calcitek, Incorporated 2320 Faraday Avenue Carlsbad, California 92008-7216
Re : K981562 Spline Dental Implant System - Spline XI Trade Name: Requlatory Class: III Product Code: EBF Dated: April 30, 1998 Received: May 1, 1998
Dear Mr. Boop:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially -equivalent-determination-assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Boop
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
S. Autman Jr
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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198156 510 (K) Number (if known) : Device Name: Spline Dental Implant_System - Spline XI
Indications For Use:
Sulzer Calcitek Dental Implant Systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement. The use of the 5.0mm implant is recommended when the quantity and density of bone would dictate the use of an implant larger than 4.0mm.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) MADITE (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dev 5100k) Number Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.