Dentin Classic Implants Pra-1033

by Dentin Implants Technologies Ltd

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	Number07290113350298 UDI-DI	Date10 Sep 2018Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK120530	Date5 Jul 2012Decided	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Withdrawn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: Dentin Classic Implants
Generic name: Screw endosteal dental implant, two-piece
Model / reference: PRA-1033

Primary DI / UDI-DI: 07290113350298
510(k) Number: K120530
FDA product code: DZE
GMDN term: Screw endosteal dental implant, two-piece

Device class: Class II
Regulation number: 872.3640
GUDID distribution status: In Commercial Distribution

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Properties

Supplied sterile
Single use
Implantable
Lot / batch number
Expiration date
Manufacturing date

Other properties (9)

Sterilise before use: 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