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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 25MM 25 FDA UDI
Model / Reference
9053834 FDA UDI
Description
SPREADERS FINGER PKG 6 25MM 25 FDA UDI

Identifiers

Primary DI / UDI-DI
D6919053834 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

A comprehensive medical device directory listing the Premier SPREADERS dental instrument, including its features, compliance information, and FAQs.

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 7037f6bc-d2c7-4fb1-8317-06dc1978a3c1 33 fields · synced Jul 8, 2026