neon

DENTAL IMPLANTS

Document: Sterilization Validation Record #29

Initiated By: VJ
RE:
Package Integrity Testing
5 Year USPSterility Test
Initiate Date: August 8th 2004
Initialed:
Date Complete: Augustfc6fh 2004

PURPOSE:

Skagfnt,hm thC Stat6d eXPir3ti0n dme °ffiVC *" (5) fol' Bico"'s «»!»«« and abutment
Dose Audit

40 implant/abutment samples that had been packaged at least five years prior to the initiate date of.hi,
XSSSSSTLabora,ories for ausp sterilityT- >•L<2££SSS?tm

Conclusions:

Since no growth was detected in any ofthe samples, it has been demonstrated that the existing
packaging maintains the product sterility after five years. This testing will be used to amrtL 5
Year expiratton date that Bicon uses for its implants and abutments PP

501 Arborway ° Boston, MA 02130 USA p tel: (800) 88-BICON or (617)524-4443 o fax: (800) 28-BICON or (617)524-0096
www.bicon.com
 Micro World Class Testing Services
ISO 9001: 2000 and ISO 17025: 1999 Certified
Laboratories, Inc.

TEST REPORT
Sample #04-04501
PO #2225

Client: Bicon
Date Received: 08/10/04
501 Arborway Date Started: 08/12/04
Boston, MA 02130 Date Completed: 08/26/04

Report to: V.J. Morgan

Sample Description: (40) Samples: Part #260-150-515 Two Part 15° Abutment for 5.0mm Implant •
Lot #: (20) 89583-0499 and Lot #:(10) 80754-0798; Part #260-150-500 Two Part 0° Abutment for 5Omni
Implant Lot #: (10) 80753-0499

Sample(s) Tested: (40) samples

Test Performed Via: Product Immersion Length of Incubation: 14 Days

Method: USP XXVII

*
Procedure: Per SOP BIC 002 rev 002 and MTL 1027 rev 002

Results: Growth was not detected in the 1-40 samples. Sterility test media controls were satisfactory.
Comments: The samples tested meet the requirements for the test method employed. The controls
tested meet the requirement for the test method employed.
The results as stated on this report are exclusive to the product defined in the "Sample
Description" section. This report may not be reproduced, except infull, without the
expressed written consent ofMicroTest Laboratories, Incorporated.
Reserve: Samples returned to client.

Analyst:
Tawana B. J<
»»te: JJAk*J1
'Group Leader, Laboratory Technician II

Approved by: m 0 -frg.0. Date: Q% (XunmA

Michelle Coach, M.B.A., B.S., RM (NRM) ^
Manager, Microbiology Laboratory

NOTE: AH service Undertaken Subject to the following General Policy: MICROTEST LABORATORIES, INC. Reports are Submitted For Exclusive Use of The Clients to
» they are addressed Their Significance Is Subject to the Adequacy and Representative Character of the samples and to the Comprehensiveness of the Tests
l ..ntlon or Surveys Made No Quotations from MICROTEST LABORATORIES. INC., Reports or use of MICROTEST LABORATORIES. INC.. Name is Pennitted Erceui
^Expressly Authorized mwriting. The liability of MICROTEST LABORATORIES. INC., with respect to services rendered shall in no event exceed the amoilint Ofthe
104 Gold Street P.O. Box 848 Agawam, MA 01001 1-800-631-1680 Fax # (413) 789-4334 www.microtesriabs.com
 MTL001BrevO23 Attachment B

TEST REQUEST FORM

CONTROLLED
(This form must be completed before testing is initiated)
(Call Customer Service if you are unsure about how to complete this form) COPY
To: MicroTest Laboratories, Inc. PO#: £A2S~
104 Gold Street
Agawam, MA 01001 MTL Quote#: Q^-MSS^
Login Fax #: 413-786-3210

Send Report To: Send Invoice To: (ifdifferent from report)

Attn: BlCOP Attn:

Oosmv) MA <5Zf}0
: ISSUED on;
Phone: (JTiJ&Q CO /O "
Fax: ^173^0 C&TK NOV 13 2002
Check all applicable:
Q STAT (50% 0 FAX Report •„ GLP Required: (additional
ORIGINAL Wl
COPY' w
IS nCL
PEL
Fee) charge)
(CFR Part 58, QA will forward
Compliance Forms)
Sample Information:
Quantity:
Description (use exact wording desired on final report): T .
—V°°. ^r *** AfeonHfeiur row. &.$*» [i*9utoir /Tq*> TW Q° AfranyJT foiS-Cw \suDM

Lot#(s): ♦5CC>
(^ftCD^* HS^
Sample Storage Requirements (ifother than ambient):
Q Refrigerated (2-8°C) • Frozen (-20°C) • Frozen (-70°C)
Sample Disposition:
Sample Disposition (Post Analysis) Q Discard Q Return FedEx* or UPS#
Sample Disposition (Reserve/Extra •-, _.
Material) u Discard • Return

Performthe following tests on this sample:

MTLTest# Test Description Extraction Additional Information"
Time/Temp/Extractant

Tc6TU\Sr7

Additional Comments: