ISMILE DENTAL PRODUCTS INC.

FDA Device Registration & Listing · Sacramento, CA, US · Registration 3007046497

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007046497
FEI Number
3007046497
Entity Name
ISMILE DENTAL PRODUCTS INC.
City/State/Country
Sacramento, CA, US
Establishment Address
4201 SIERRA POINT DR STE 102, Sacramento, CA 95834, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
iSmile Dental Products, Inc. (Owner Number: 10052362)
Owner / Operator Contact Address
4201 Sierra Point Drive, Ste 102, Sacramento, CA 95834, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K133070
PMA Number
N/A

All Registered Proprietary Names

iSmile Dental Products iSmile Dental Products

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2023-05-03
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2023-05-03

Official Correspondent

Bryan Shields

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

iSmile Dental Products, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K201622 Guangdong Kingfa Sci. & Tech.Co., Ltd. Medical surgical mask 2020-11-24
K881618 3M Company ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK 1988-05-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007046497. Last updated year: 2026. Please use registration number 3007046497 when referencing this establishment in official correspondence.
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