SILGAN UNICEP PACKAGING, LLC.

FDA Device Registration & Listing · SANDPOINT, ID, US · Registration 3028011

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
3028011
FEI Number
1000150986
Entity Name
SILGAN UNICEP PACKAGING, LLC.
City/State/Country
SANDPOINT, ID, US
Establishment Address
1702 Industrial Dr, SANDPOINT, ID 83864, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Silgan Unicep (Owner Number: 10082972)
Owner / Operator Contact Address
1702 Industrial Drive, Sandpoint, ID 83864, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Zeltiq Therma-Trol

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OOK Dermal Cooling Pack/Vacuum/Massager General, Plastic Surgery Class 2 878.4340 2021-10-18
ELL Teeth, Porcelain Dental Class 2 872.3920 2021-10-18
KJJ Cleanser, Root Canal Unknown Class U N/A 2021-10-18
JAC System, X-Ray, Film Marking, Radiographic Radiology Class 1 892.1640 2021-10-18
LBH Varnish, Cavity Dental Class 2 872.3260 2021-10-18

Official Correspondent

Steven Van Eps

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Silgan Unicep
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
1000150986 Silgan Unicep Packaging, LLC. Spokane, WA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K033295 Novamin Technology, Inc. BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN 2003-10-28

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0011-2020 Inter-Med Llc U
Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF + 92) + (2) 30ga Irrigation Tips + (1) Micro Aspirator with Tip, REF 504700
Z-0012-2020 Inter-Med Llc U
Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300
Z-0013-2020 Inter-Med Llc U
Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes, REF 502315
Z-0014-2020 Inter-Med Llc U
Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350
Z-0015-2020 Inter-Med Llc U
Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 502355

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3028011. Last updated year: 2026. Please use registration number 3028011 when referencing this establishment in official correspondence.
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