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Precedent PRL15

by Reliance Orthodontic 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

None found

in data synced 22 Oct 2026

Documents

510(k) K934405

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

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD798PRL150 UDI-DI Date15 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK934405 Date21 Jan 1994DecidedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Precedent
Generic name
Glass ionomer dental cement
Model / Ref / Catalog
PRL15
Primary DI / UDI-DI
D798PRL150
510(k) Number
FDA product code
DYH
GMDN term
Glass ionomer dental cement
Device class
Class II
Regulation number
872.3750
GUDID distribution status
In Commercial Distribution

Related devices

Category: Glass ionomer dental cement

Cleared under the same submission (K934405)

Other devices from Reliance Orthodontic Products, Inc.

See all devices from Reliance Orthodontic Products, Inc. →

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