iSmile 45-1505

by Ismile Dental Products Inc.

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	Number00816419020047 UDI-DI	Date21 Jun 2023Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK133070	Date22 Jun 2015Decided	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Withdrawn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: iSmile
Generic name: Surgical/medical face mask, non-antimicrobial, single-use
Model / Ref / Catalog: 45-1505

Primary DI / UDI-DI: 00816419020047
510(k) Number: K133070
FDA product code: FXX
GMDN term: Surgical/medical face mask, non-antimicrobial, single-use

Device class: Class II
Regulation number: 878.4040
GUDID distribution status: In Commercial Distribution

Other devices from Ismile Dental Products Inc.

iSmile 25-3004

Class I
iSmile 45-0001

Class II
iSmile 45-1540

Class II
iSmile 45-2503

Class II
iSmile 65-6015

Class II
iSmile 45-0030

Class II

See all devices from Ismile Dental Products Inc. →

Properties

Single use
Lot / batch number

Other properties (13)

Supplied sterile: No
Sterilise before 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
Serial number: No
Expiration date: No
Manufacturing date: No