FDA.report

Salvin Carbide Tipped Locking Crown Gripper

Primary DI
00841336102439
Brand
Salvin Carbide Tipped Locking Crown Gripper
Company
Salvin Dental Specialties, Inc.
Model
CROWN-GRIP-LOCKING
Published
2023-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EISRemover, Crown

Product Code Classifications

CodeDeviceSpecialtyClass
EISRemover, CrownDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841336102439PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841336102439008413361024398413361024390841336102439

GMDN Terms

TermDefinition
Dental implant/prosthesis handling forcepsA hand-held manual dental instrument designed for grasping and holding a dental implant and/or prosthesis (e.g., crown, bridge, screw) during its application to a patient's oral cavity. It typically has a tweezers-like design consisting of two conjoined blades with serrated tips at the working end; some types have graduated markings on the tips for gauging. It is made of metal [e.g., high-grade stainless steel, titanium (Ti)] and is available in various sizes. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
113344790
Device count
1
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
true

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