FDA.reportPublic FDA data

P.P. ApicalShaper Z40

Primary DI
00810092939221
Brand
P.P. ApicalShaper Z40
Company
NUSMILE, LTD.
Model
ZASPP00Z40
Device description
100 units
Published
2022-07-15
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKNPoint, Paper, Endodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKNPoint, Paper, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810092939221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810092939221008100929392218100929392210810092939221

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic paper pointA non-medicated absorbent point used in endodontic procedures that has been sterilized once in a manner approved by the manufacturer. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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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00810118106910NuSmile ReVIVE CrownsU3704L2025-11-26
00810118106927NuSmile ReVIVE CrownsU4704L2025-11-26
00810118106934NuSmile ReVIVE CrownsDLL1706L2025-11-26
00810118106941NuSmile ReVIVE CrownsDLL2706L2025-11-26
00810118106958NuSmile ReVIVE CrownsDLL3706L2025-11-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06978880220044ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
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06978880220068ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
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06978880220099ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
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