SIMPLANT®

GUDID 07392532177064

SIMPLANT Guide

DENTSPLY IH, INC.

Surgical drill guide, single-use, sterile
Primary Device ID07392532177064
NIH Device Record Key2cd2b05b-7884-4597-8284-f385d91e7565
Commercial Distribution StatusIn Commercial Distribution
Brand NameSIMPLANT®
Version Model Number37000
Company DUNS847337201
Company NameDENTSPLY IH, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)531-3481
Emailimplants-na-cs@dentsply.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, do not expose to UV-light and moisture

Device Identifiers

Device Issuing AgencyDevice ID
GS107392532177064 [Primary]

FDA Product Code

NDPAccessories, implant, dental, endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07392532177064]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-22
Device Publish Date2016-09-30

On-Brand Devices [SIMPLANT®]

07392532185236Other Custom Guide
07392532185229Extra Custom Guide
07392532177064SIMPLANT Guide

Trademark Results [SIMPLANT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SIMPLANT
SIMPLANT
79016792 3171725 Live/Registered
DENTSPLY Implants NV
2004-10-27
SIMPLANT
SIMPLANT
77848515 3877954 Dead/Cancelled
WomanCare Global LLC
2009-10-14

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