Sonus Nose Cone 806-1105

by Engler Engineering Corp. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00862872000348 UDI-DI	Date4 May 2021Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name: Sonus Nose Cone
Generic Name: Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Model / Ref / Catalog: 806-1105

Primary DI / UDI-DI: 00862872000348
510(k) Number: K811396
FDA Product Code: ELC
GMDN Term: Ultrasonic dental scaling/debridement system handpiece tip, periodontal

Device Class: Class II
Regulation Number: 872.4850
GUDID distribution status: In Commercial Distribution

MRI Safety: MR Safe

Other devices from Engler Engineering Corp.

Engler 25K Series S 4

Class II
Engler 25K Series S 1

Class II
Sonus Stack (Insert) A47030

Class II
SONUS V Sonus V

Class II
Sonus M 1

Class II
Sonus M4 M 4

Class II

See all devices from Engler Engineering Corp. →

Properties

Other properties (14)

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