Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031606505

FEI Number

3031606505

Entity Name

ENPUNO BIOTECHNOLOGY CO., LTD

City/State/Country

Changsha Hunan, CN

Establishment Address

No. 101,201,Haiping Park Production Plant 3,No.229, Guyuan Road Changsha High-tech Development Zone, Changsha Hunan 410205, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Enpuno Biotechnology Co., Ltd (Owner Number: 10090947)

Owner / Operator Contact Address

No. 101,201,Haiping Park Production Plant 3,No.229, Guyuan Road Changsha High-tech Development Zone, Changsha, CN-HN 410205, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250710

PMA Number

N/A

All Registered Proprietary Names

Root canal repair materials (nRoot BP) Injectable Root Canal Bioceramic Sealer(nRoot SP),NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2025-09-28
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2025-06-15

Official Correspondent

Hao He

US Agent Details

James St. Wu Business: Humiss Inc. Email: fda-reg@humiss.com Phone: (720) 7595888

Related Public Records

Same Entity

Enpuno Biotechnology Co., Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031606505. Last updated year: 2026. Please use registration number 3031606505 when referencing this establishment in official correspondence.