Healing Cap MP CAP4.5: FDA 510(k) K201981

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK201981	Date27 Aug 2020Decided	StatusActive
United States	GUDID listing	Number08800090600973 UDI-DI	Date14 Aug 2020Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK152520	Date25 Jan 2016Decided	StatusActive

Official records

AccessGUDID record UDI-DI 08800090600973
FDA 510(k) database 510(k) number K201981
FDA 510(k) database 510(k) number K152520

Across registries

2 registries list this device

FDA 510(k) K201981 decided 27 Aug 2020 Active· +1 more in the status table
FDA GUDID UDI-DI 08800090600973 listed 14 Aug 2020 Listed

Timeline

3 dated events

25 Jan 2016 Cleared FDA 510(k) K152520
14 Aug 2020 Listed FDA GUDID 08800090600973
27 Aug 2020 Cleared FDA 510(k) K201981

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Healing Cap
Generic name: Dental implant system
Model / reference: MP CAP4.5

Primary DI / UDI-DI: 08800090600973
510(k) Number: K152520
K201981
FDA product code: NHA
GMDN term: Dental implant system

Device class: Class II
Regulation number: 872.3630
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Category: Dental implant system

Cleared under the same submission (K152520)

and 8 more cleared under K152520

Cleared under the same submission (K201981)

and 8 more cleared under K201981

Similar devices

Also classified as Dental implant system.

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TRI B — Tri Dental Implants Int. AG Class II
Denture Retention Attachments Brown Liner 10 Pack — IMPLANT ATTACHMENTS LLC Class II

Similar devices in this category

Other devices filed under Dental implant system.

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Properties

Sterilise before use
Single use
Implantable
Prescription use
Lot / batch number
Serial number
Manufacturing date

Other properties (8, all answered No)