OWL DENTAL

FDA Device Registration & Listing · San Leandro, CA, US · Registration 3030268763

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
3030268763
FEI Number
3030268763
Entity Name
OWL DENTAL
City/State/Country
San Leandro, CA, US
Establishment Address
345 Estudillo Ave # 211, San Leandro, CA 94577, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Owl Dental (Owner Number: 10095355)
Owner / Operator Contact Address
345 Estudillo Ave., 211, San Leandro, CA 94577, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Owl Impression Material Owl Night Guard Owl Impression Tray

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ELW Material, Impression Dental Class 2 872.3660 2026-03-03
OCO Mouthguard, Migraine/Tension Headache Unknown Class U N/A 2026-03-03
OBR Mouthguard, Over-The-Counter Unknown Class U N/A 2026-03-03
MQC Mouthguard, Prescription Unknown Class U N/A 2026-03-03
EHY Tray, Impression, Preformed Dental Class 1 872.6880 2026-03-03

Official Correspondent

Jennifer Day

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Owl Dental
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
K952614 Dentsply Intl. JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL 1996-08-13

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030268763. Last updated year: 2026. Please use registration number 3030268763 when referencing this establishment in official correspondence.
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