CLA-10

GUDID 04560264579958

NAKANISHI INC.

Ultrasonic dental scaling/debridement system
Primary Device ID04560264579958
NIH Device Record Keyb1fea64d-d171-48df-83f0-b4715fca8b26
Commercial Distribution StatusIn Commercial Distribution
Brand NameCLA-10
Version Model NumberCLA-10
Company DUNS690710546
Company NameNAKANISHI INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104560264579958 [Direct Marking]
GS104589551387137 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELCScaler, ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-29
Device Publish Date2026-01-21

Devices Manufactured by NAKANISHI INC.

04589551387168 - Tip Cover L2026-01-29
04589551387151 - Tip Cover S2026-01-29
04589551382828 - E TIP WRENCH2026-01-29
04589551387144 - Varios2026-01-29
04560264579958 - CLA-102026-01-29
04560264579958 - CLA-102026-01-29
04589551388974 - 3 Mode Select Switch2026-01-29
04589551383863 - Varios2026-01-14
04589551383870 - Varios2026-01-14

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