FDA.report

NAVICORE PINK GUTTA PERCHA OBTURATORS 5+1/pk # 20

Primary DI
D77813040200
Brand
NAVICORE PINK GUTTA PERCHA OBTURATORS 5+1/pk # 20
Company
SCOTT'S DENTAL SUPPLY L.L.C.
Model
130-4020
Catalog number
130-4020
Device description
GUTTA PERCHA OBTURATORS (6/pack) Contains: 5 obturators, 1 size verifier, Size: 20; For more information: https://www.scottsdental.com/catalog/product/view/id/31554/s/navicore-obturators/
Published
2021-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EKMGUTTA-PERCHA

Product Code Classifications

CodeDeviceSpecialtyClass
EKMGutta-PerchaDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D77813040201PrimaryHIBCC0
D77813040200Unit of UseHIBCC0

GMDN Terms

TermDefinition
Warm-bonded endodontic obturation system obturatorA hand-held manual dental instrument designed for direct warm bonding during an endodontic obturation procedure. It is preloaded (encased) with a resin-based sealing, filling, and core material at its distal working end which is subsequently heated in a dedicated oven to a specified temperature prior to delivery of the materials into a root canal. It is available in a variety of root canal sizes. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)901-3368info@scottsdental.com

Regulatory Flags

DUNS number
137217043
Device count
6
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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