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Premier SPREADERS

FDA UDI

Class I (US FDA UDI)

by Premier Dental Products Company

Identity

Trade Name
Premier SPREADERS FDA UDI
Generic Name
Manual endodontic filling material spreader FDA UDI
Device Name
SPREADERS FINGER PKG 6 21MM 20 FDA UDI
Model / Reference
9053816 FDA UDI
Description
SPREADERS FINGER PKG 6 21MM 20 FDA UDI

Identifiers

Primary DI / UDI-DI
D6919053816 FDA UDI
FDA Product Code
EKK FDA UDI
GMDN Term
Manual endodontic filling material spreader FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4565 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Manual endodontic filling material spreader

Premier SPREADERS by Premier Dental Products Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Manual endodontic filling material spreader.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Premier Dental Products Company

Sources (1)

  • FDA UDI 71edf014-c439-451c-a01d-cc86dd9cbe6e 33 fields · synced Jun 8, 2026