FDA.report

Z Micro-Shaper .02/20

Primary DI
00810092938705
Brand
Z Micro-Shaper .02/20
Company
NUSMILE, LTD.
Model
UDMS2002
Device description
3 units
Published
2022-07-11
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
EKSFile, Pulp Canal, Endodontic

Product Code Classifications

CodeDeviceSpecialtyClass
EKSFile, Pulp Canal, EndodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810092938705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810092938705008100929387058100929387050810092938705

GMDN Terms

TermDefinition
Manual non-rotary dental instrument handleA hand-held, manual device designed to hold and facilitate manipulation of a non-powered, non-rotary dental instrument (e.g., endodontic file/rasp, implant extractor). It is designed to accept the patient-contact endpiece (not included) for ease of handling. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
832-540-5964plara@nusmile.com

Regulatory Flags

DUNS number
185497372
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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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00810118106927NuSmile ReVIVE CrownsU4704L2025-11-26
00810118106934NuSmile ReVIVE CrownsDLL1706L2025-11-26
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