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Diamond D 1013018

by Keystone Industries

Diamond D 1013018 is a Class II device made by Keystone Industries, cleared under FDA 510(k) K032773 on 23 Sep 2003 and listed in FDA GUDID since 15 Sep 2016 (UDI-DI H66810130181), active as of 23 Oct 2026.

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 23 Oct 2026

Documents

510(k) K032773

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberH66810130181 UDI-DI Date15 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK032773 Date23 Sep 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K032773 decided 23 Sep 2003 Active
  • FDA GUDID UDI-DI H66810130181 listed 15 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K032773
  2. Listed FDA GUDID H66810130181

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Diamond D
Generic name
Dental appliance fabrication material, resin
Model / Ref / Catalog
1013018
Primary DI / UDI-DI
H66810130181
510(k) Number
FDA product code
EBI
GMDN term
Dental appliance fabrication material, resin
Device class
Class II
Regulation number
872.3760
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 1 Quart
Total Volume — 0.95 Liter

Similar devices in this category

Other devices filed under Dental appliance fabrication material, resin.

Other devices from Keystone Industries

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Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)