Pre-Finisher 190-048

by Tp Orthodontics, 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 23 Oct 2026

Documents

FDA submission, from GUDID

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	Number00192029041505 UDI-DI	Date15 Feb 2021Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK780619	Date28 Jun 1978Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00192029041505
FDA 510(k) database 510(k) number K780619

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Pre-Finisher
Generic name: Orthodontic retainer
Model / reference: 190-048

Primary DI / UDI-DI: 00192029041505
510(k) Number: K780619
FDA product code: KMY
GMDN term: Orthodontic retainer

Device class: Class I
Regulation number: 872.5525
GUDID distribution status: In Commercial Distribution

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Pre-Finisher Introductory Kit 190-110

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Class I

See all devices from Tp Orthodontics, Inc. →

Properties

Single use
Lot / batch number
Expiration date

Other properties (12)

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
Manufacturing date: No