Etchant ET18

by Pulpdent Corporation

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberD701ET182 UDI-DI	Date1 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK022492	Date11 Oct 2002Decided	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Etchant
Generic name: Dental tooth-etching solution
Model / reference: ET18
Description: SEMI-GEL, 35% PHOSPHORIC ACID 18 gm bottle

Primary DI / UDI-DI: D701ET182
510(k) Number: K022492
FDA product code: EBF
GMDN term: Dental tooth-etching solution

Device class: Class II
Regulation number: 872.3690
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Lot / batch number
Expiration date

Other properties (12)

Supplied sterile: No
Sterilise before use: No
Single use: No
Implantable: No
Contains latex: No
Over-the-counter: No
Convenience kit: No
Combination product: No
HCT/P: No
Premarket exempt: No
Serial number: No
Manufacturing date: No