NAVIFILE GOLD NITI FILES 6/pk .04 TAPER 25mm # 20 130-5420

by Scott's Dental Supply L.L.C.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberD77813054201 UDI-DI	Date27 Feb 2021Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: NAVIFILE GOLD NITI FILES 6/pk .04 TAPER 25mm # 20
Generic Name: Rotary/reciprocating endodontic file/rasp, single-use
Model / Ref / Catalog: 130-5420

Primary DI / UDI-DI: D77813054201
FDA Product Code: EKS
GMDN Term: Rotary/reciprocating endodontic file/rasp, single-use

Device Class: Class I
Regulation Number: 872.4565
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

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Properties

Single Use
Premarket Exempt

Other properties (12)

Sterile: No
Implantable: No
Contains Latex: No
Prescription Use: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Lot / Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No