STARTER PACK B4U STARTER-PACK-B4U.

GUDID D7702707123

STARTER PACK B4U

SWEDEN & MARTINA SPA

Synthetic gutta-percha
Primary Device IDD7702707123
NIH Device Record Key04cf1180-cc66-4ab3-8f37-1e229555a9a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTARTER PACK B4U
Version Model NumberSTARTER-PACK-B4U.
Catalog NumberSTARTER-PACK-B4U.
Company DUNS433815198
Company NameSWEDEN & MARTINA SPA
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 Batchtrue
Serial Numbertrue
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

Phone844.862.7846
Emailinfo.us@sweden-martina.com
Phone844.862.7846
Emailinfo.us@sweden-martina.com
Phone844.862.7846
Emailinfo.us@sweden-martina.com
Phone844.862.7846
Emailinfo.us@sweden-martina.com
Phone844.862.7846
Emailinfo.us@sweden-martina.com
Phone844.862.7846
Emailinfo.us@sweden-martina.com
Phone844.862.7846
Emailinfo.us@sweden-martina.com
Phone844.862.7846
Emailinfo.us@sweden-martina.com
Phone844.862.7846
Emailinfo.us@sweden-martina.com
Phone844.862.7846
Emailinfo.us@sweden-martina.com
Phone844.862.7846
Emailinfo.us@sweden-martina.com
Phone844.862.7846
Emailinfo.us@sweden-martina.com
Phone844.862.7846
Emailinfo.us@sweden-martina.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD7702707123 [Primary]

FDA Product Code

EKMGutta-Percha

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-10-06
Device Publish Date2025-09-26

Devices Manufactured by SWEDEN & MARTINA SPA

D7702707123 - STARTER PACK B4U2025-10-06STARTER PACK B4U
D7702707123 - STARTER PACK B4U2025-10-06 STARTER PACK B4U
D7701556003 - PRAMA RF IMPLANT ZIRTI2025-08-12 PRAMA RF IMPLANT ZIRTI WIDE THREAD D. 3.80 H. 18 MM
D7701556073 - PRAMA RF IMPLANT ZIRTI2025-08-12 PRAMA RF IMPLANT ZIRTI WIDE THREAD D. 4.25 H. 18 MM
D7701609403 - STOP FOR CONICAL DRILL 2025-08-01 STOP FOR CONICAL DRILL D.2.00-D.2.50 - H.18MM
D7701609413 - STOP FOR CONICAL DRILL 2025-08-01 STOP FOR CONICAL DRILL D.2.00-D.2.50 - H.19MM
D7701609433 - STOP FOR CONICAL DRILL 2025-08-01 STOP FOR CONICAL DRILL D.2.00-D.2.50 - H.21MM
D7701609443 - STOP FOR CONICAL DRILL 2025-08-01 STOP FOR CONICAL DRILL D.2.00-D.2.50 - H.22MM
D7701609463 - STOP FOR CONICAL DRILL 2025-08-01 STOP FOR CONICAL DRILL D.2.00-D.2.50 - H.24MM

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