Infinity External Hex Implant System 49350001

GUDID 00614950006649

SINGLE TOOTH ABUTMENT KIT 3.5= HD (THE STAK) ZIMMER

ACE SURGICAL SUPPLY CO., INC.

Screw endosteal dental implant, one-piece
Primary Device ID00614950006649
NIH Device Record Key58ce367f-bcc8-46df-91e0-6bd0d96b606d
Commercial Distribution StatusIn Commercial Distribution
Brand NameInfinity External Hex Implant System
Version Model Number49350001
Catalog Number49350001
Company DUNS042763706
Company NameACE SURGICAL SUPPLY CO., INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(508)588-3100
Emailritaknight@acesurgical.com
Phone+1(508)588-3100
Emailritaknight@acesurgical.com

Device Dimensions

Width4.5 Millimeter
Width4.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100614950006649 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00614950006649]

Radiation Sterilization

[00614950006649]

Radiation Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-24

On-Brand Devices [Infinity External Hex Implant System]

00614950007042PREPABLE ABUTMENT Ø6.0MM 2MM HEIGHT [NOBELBIOCARE]
00614950007035IMPRESSION COPING Ø6.0MM UNI-TORX GUIDE PINS GREEN [NOBLEBIOCARE]
00614950007028UNI TORX SCREW BLACK Ø6.0MM [NOBELBIOCARE]
00614950007011SINGLE TOOTH ABUTMENT KIT 6.0= HD (THE STAK) NOBEL BIOCARD
00614950007004CONTOURED HEALING CAP Ø5MM 5MM HEIGHT 1.25 HEX [NOBELBIOCARE]
00614950006991CONTOURED HEALING CAP Ø5MM 3MM HEIGHT 1.25 HEX [NOBELBIOCARE]
00614950006984HEALING CAP Ø5MM 5MM HEIGHT [NOBELBIOCARE]
00614950006977HEALING CAP Ø5MM 3MM HEIGHT [NOBELBIOCARE]
00614950006960HEALING CAP Ø5MM .05MM HEIGHT [NOBELBIOCARE]
00614950006953PREPABLE ABUTMENT Ø5MM 2MM HEIGHT W/UNI TORX SCREW [NOBELBIOCARE]
00614950006946ENGAGING TI BASE F/WAXING SLEEVE & UNI-TORX SCREW Ø5MM BLUE [NOBELBIOCARE]
00614950006939UNI TORX SCREW BLACK Ø5.0MM [NOBELBIOCARE]
00614950006922CONTOURED HEALING CAP Ø4.3MM 5MM HEIGHT 1.25 HEX [NOBELBIOCARE]
00614950006915CONTOURED HEALING CAP Ø4.3MM 3MM HEIGHT 1.25 HEX [NOBELBIOCARE]
00614950006908HEALING CAP Ø4.3MM 5.0 HEIGHT [NOBELBIOCARE]
00614950006892HEALING CAP Ø4.3MM 3MM HEIGHT [NOBELBIOCARE]
00614950006885HEALING CAP Ø4.3MM .05MM HEIGHT [NOBELBIOCARE]
00614950006878PREPABLE ABUTMENT Ø4.3MM 2MM HEIGHT W/SCREW [NOBELBIOCARE]
00614950006861MULTI USE ABUTMENT 1 PIECE Ø4.3MM 1MM HEIGHT TITANIUM [NOBELBIOCARE]
00614950006854ENGAGING TI BASE F/WAXING SLEEVE & UNI TORX-SCREW Ø4.3MM YELLOW[NOBELBIOCARE]
00614950006847UNI TORX SCREW BLACK Ø4.3MM [NOBELBIOCARE]
00614950006830SINGLE TOOTH ABUTMENT KIT 4.3= HD (THE STAK) NOBEL BIOCARD
00614950006823COUNTOURED HEALING CAP Ø3.5MM 5MM HEIGHT 1.25 HEX [NOBELBIOCARE]
00614950006816CONTOURED HEALING CAP Ø3.5MM 3MM HEIGHT 1.25MM HEX [NOBELBIOCARE]
00614950006809HEALING CAP Ø3.5MM 5MM HEIGHT [NOBELBIOCARE]
00614950006793HEALING CAP Ø3.5MM 3MM HEIGHT [NOBELBIOCARE]
00614950006786HEALING CAP Ø3.5MM .05MM HEIGHT [NOBELBIOCARE]
00614950006779PREPABLE ABUTMENT Ø3.5MM 2MM HEIGHT W/UNI TORX SCREW [NOBELBIOCARE]
00614950006762MULTI USE ABUTMENT 1 PIECE Ø3.5MM 3MM HEIGHT TITANIUM [NOBELBIOCARE]
00614950006755MULTI USE ABUTMENT 1 PIECE Ø3.5MM 2MM HEIGHT TITANIUM [NOBELBIOCARE]
00614950006748MULTI USE ABUTMENT 1 PIECE TI Ø3.5MM 1MM HEIGHT [NOBELBIOCARE]
00614950006731ENGAGING TI BASE F/WAXING SLEEVE & UNI-TORX SCREW Ø3.5MM RED [NOBELBIOCARE]
00614950006724SELECT UNI TORX SCREW 3.5MM=D
00614950006717SINGLE TOOTH ABUTMENT KIT 3.5= HD (THE STAK) NOBEL BIOCARE
00614950006700HEALING CAP Ø4.5MM 6.0MM HEIGHT (ZIMMER)
00614950006694HEALING CAP Ø4.5MM 4.0MM HEIGHT (ZIMMER)
00614950006687HEALING CAP Ø4.5MM 2.0MM HEIGHT (ZIMMER)
00614950006670HEALING CAP Ø4.5MM .5MM HEIGHT (ZIMMER)
0061495000666325°ANGLE PREPABLE ABUTMENT Ø4.5MM WITH .050" HEX SCREW [ZIMMER]
00614950006656ENGAGING TI BASE F/ ZIRCONIA ABUTMENT Ø4.5MM W/SCREW & PIN [ZIMMER]
00614950006649SINGLE TOOTH ABUTMENT KIT 3.5= HD (THE STAK) ZIMMER
00614950006632HEALING CAP Ø3.5MM 6.0MM HEIGHT (ZIMMER)
00614950006625HEALING CAP Ø3.5MM 4.0MM HEIGHT (ZIMMER)
00614950006618HEALING CAP Ø3.5MM 2.0MM HEIGHT (ZIMMER)
00614950006601PREPABLE ABUTMENTS Ø3.5MM WITH .050" HEX SCREW [ZIMMER] 2 PIECE
00614950006595ENGAGING TI BASE F/ ZIRCONIA ABUTMENT Ø3.5MM W/SCREW & PIN (ZIMMER)
00614950005543INFINITY EXTERNAL 4.75X15.0MM Ø5.0HD HEX IMPLANT TI CP GRADE 4
00614950005536INFINITY EXTERNAL 4.75X13MM Ø5.0HD HEX IMPLANT TI CP GRADE 4
00614950005529INFINITY EXTERNAL 4.75X11.5MM Ø5.0HD HEX IMPLANT TI CP GRADE 4
00614950005512INFINITY EXTERNAL 4.75X10.0MM Ø5.0HD HEX IMPLANT TI CP GRADE 4
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