Who is the manufacturer of Epic 980?

Biolase, Inc. filed the 510(k) submission for Epic 980 (K193486).

What is the FDA product code for Epic 980?

GEX. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Epic 980?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Epic 980?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Epic 980

Q: What are the predicate devices for Epic 980?

Epic 980 (K192430); QuickLase 980, 810 & Dual (K100474); SIROLase Advance (K103753); Elumi 810+980 (K152032); Curative980 Diode Laser (K082445).

K193486 · Biolase, Inc. · GEX · Mar 16, 2020 · General, Plastic Surgery

Device Facts

Record ID	K193486
Device Name	Epic 980
Applicant	Biolase, Inc.
Product Code	GEX · General, Plastic Surgery
Decision Date	Mar 16, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Dental Soft Tissue Indications Incision, excision, vaporization, ablation and coagulation of oral soft-tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications: - Excisional and incisional biopsies - Exposure of unerupted teeth - Fibroma removal - Frenectomy - Frenotomy - Gingival troughing for crown impressions - Gingivectomy - Gingivoplasty - Gingival incision and excision - Hemostasis and coagulation - Implant recovery - Incision and drainage of abscess - Leukoplakia - Operculectomy - Oral papillectomies - Pulpotomy - Pulpotomy as an adjunct to root canal therapy - Reduction of gingival hypertrophy - Soft-tissue crown lengthening - Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa - Vestibuloplasty - Tissue retraction for impression - Laser soft-tissue curettage - Laser removal of diseased, inflamed and necrosed soft-tissue within the periodontal pocket - Sulcular debridement (removal of diseased, inflamed and necrosed soft-tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth mobility) - Reduction of bacterial level (decontamination) and inflammation - Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium - Lesion (tumor) removal - Removal of hyperplastic tissues - Laser assisted flap surgery - Removal of granulation tissue Whitening - Light activation for bleaching materials for teeth whitening - Laser-assisted whitening/bleaching of teeth Pain Therapy - Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.

Device Story

Epic 980 is a portable dental diode laser system; emits 980nm infrared energy via solid-state diode. Energy transmitted through flexible fiber optic cable to handpiece with single-use disposable tips. Operated by clinician via touch screen console and wireless footswitch. Used for oral soft-tissue surgery, teeth whitening, and pain therapy (topical heating). Provides precise tissue interaction for incision, excision, and coagulation; aids in periodontal decontamination and inflammation reduction. Benefits include minimally invasive tissue management, improved hemostasis, and temporary pain relief. Device is used in dental clinic settings.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing and comparison of technological characteristics to legally marketed predicate devices.

Technological Characteristics

Solid-state diode laser; 980nm wavelength; 10W max power; continuous/pulsed modes. Delivery via fiber optic cable, handpiece, and single-use quartz tips (200-400μm). Materials: medical-grade plastics, stainless steel, aluminum, brass. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, IEC 80601-2-60. Software developed per IEC 62304.

Indications for Use

Indicated for oral soft-tissue surgical procedures (incision, excision, ablation, coagulation), dental whitening, and temporary relief of minor muscle/joint pain/stiffness in dental patients.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

Epic 980 (K192430)
QuickLase 980, 810 & Dual (K100474)
SIROLase Advance (K103753)
Elumi 810+980 (K152032)
Curative980 Diode Laser (K082445)

Related Devices

K192430 — Epic 980 · Biolase, Inc. · Dec 4, 2019
K172771 — Epic Pro 940 · Biolase, Inc. · Nov 29, 2017
K162114 — Photon, Photon Plus · Zolar Technology & Mfg Co., Inc. · Dec 12, 2016
K232222 — Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo) · Medency S.R.L. · Nov 27, 2023
K121286 — EPIC 10 · Biolase Technology, Inc. · Sep 28, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Biolase, Inc Alicia Mszyca Director, Regulatory Affairs 4 Cromwell Irvine, California 92618 Re: K193486 Trade/Device Name: Epic 980 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: December 13, 2019 Received: December 17, 2019 Dear Alicia Mszyca: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Jessica Mavadia-Shukla, Ph.D. Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K193486 Device Name Epic 980 ### Indications for Use (Describe) Dental Soft Tissue Indications Incision, excision, vaporization, ablation of oral soft-tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications: - · Excisional and incisional biopsies - · Exposure of unerupted teeth - Fibroma removal - · Frenectomy - · Frenotomy - · Gingival troughing for crown impressions - · Gingivectomy - · Gingivoplasty - · Gingival incision and excision - Hemostasis and coagulation - · Implant recovery - · Incision and drainage of abscess - · Leukoplakia - · Operculectomy - · Oral papillectomies - · Pulpotomy - · Pulpotomy as an adjunct to root canal therapy - Reduction of gingival hypertrophy - · Soft-tissue crown lengthening - · Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa - · Vestibuloplasty - · Tissue retraction for impression - · Laser soft-tissue curettage - · Laser removal of diseased, inflamed and necrosed soft-tissue within the periodontal pocket · Sulcular debridement (removal of diseased, inflamed and necrosed soft-tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth mobility) - · Reduction of bacterial level (decontamination) and inflammation • Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium - · Lesion (tumor) removal - · Removal of hyperplastic tissues - · Laser assisted flap surgery - · Removal of granulation tissue ### Whitening - · Light activation for bleaching materials for teeth whitening - · Laser-assisted whitening/bleaching of teeth {3}------------------------------------------------ ### Pain Therapy · Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle. Type of Use (Select one or both, as applicable) | ✖ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| |----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the word "BIOLASE" in a bold, sans-serif font. The word is all capitalized and is a dark blue color. The background is white, which makes the word stand out. ### 510(k) SUMMARY #### I. SUBMITTER Biolase, Inc. 4 Cromwell Irvine, CA 92618 USA Tel: (949) 226-8471 Fax: (949) 273-6688 Contact Person: Alicia Mszyca Date Prepared: December 13, 2019 #### II. DEVICE | Name of Device: | Epic 980 | |----------------------|----------------------------------------------------------------------------------------------------------| | Common Name: | Dental Diode Laser | | Classification Name: | Laser surgical instrument for use in general and plastic surgery and in dermatology (21 CFR 878.4810) | | Device Class: | II | | Product Code: | GEX | ### III. PREDICATE DEVICES Epic 980 (K192430) QuickLase 980, 810 & Dual (K100474) SIROLase Advance (K103753) Elumi 810+980 (K152032) Curative980 Diode Laser (K082445) #### IV. DEVICE DESCRIPTION The Epic 980 diode laser is a surgical and therapeutic device designated for a wide variety of oral soft-tissue procedures and dental whitening as well as for use in providing a temporary relief of minor pain. The device uses a solid-state laser diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to a handpiece that emits the energy to the treatment site. The laser is comprised of a base console, a wireless footswitch which activates the laser and a detachable delivery system consisting of a fiber optic cable, surgical handpiece and single-use disposable tips designed and optimized for different applications. {5}------------------------------------------------ ## V. INDICATIONS FOR USE STATEMENT Dental Soft Tissue Indications Incision, excision, vaporization, ablation and coagulation of oral soft-tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications: - Excisional and incisional biopsies - Exposure of unerupted teeth ● - Fibroma removal ● - Frenectomy - Frenotomv - Gingival troughing for crown impressions ● - Gingivectomy - Gingivoplasty - Gingival incision and excision - Hemostasis and coagulation - Implant recovery - Incision and drainage of abscess - Leukoplakia - Operculectomy - Oral papillectomies - Pulpotomy - Pulpotomy as an adjunct to root canal therapy - Reduction of gingival hypertrophy - Soft-tissue crown lengthening - . Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa - Vestibuloplasty - Tissue retraction for impression - Laser soft-tissue curettage - Laser removal of diseased, inflamed and necrosed soft-tissue within the periodontal pocket - Sulcular debridement (removal of diseased, inflamed and necrosed soft-tissue ● in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility) - Reduction of bacterial level (decontamination) and inflammation ● - Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium - Lesion (tumor) removal - Removal of hyperplastic tissues ● - Laser assisted flap surgery - Removal of granulation tissue {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "BIOLASE" in all capital letters. The word is written in a bold, sans-serif font. The color of the text is a dark blue. Whitening - · Light activation for bleaching materials for teeth whitening - · Laser-assisted whitening/bleaching of teeth Pain Therapy - · Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary ### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS VI. The Epic 980 subject device is the same as Epic 980 (K192430) except for the expanded indications for use already cleared for devices: Ouicklase 810, 980, Dual + (K100474) by QuickLase Limited, SIROLaser Advance (K103753) by Sirona, Elumi 810 + 980 (K152032) by Azena Medical, LLC and Curative980 (K082445) by OroScience, Inc. The Epic 980 shares the same technological characteristic as the predicate devices including: - the same laser source: solid state diode producing invisible infrared energy - the same wavelength: 980nm - the same intended use: incision, excision, vaporization, ablation and coagulation of ● oral soft tissue - the same indications for use - . the same patient-contacting components: glass fiber used in contact and non-contact mode the same use environment - the same tissue type and application regimen - the same principle of operation and emission mode: continuous wave, pulsed or . both the same control mechanism - similar design consisting of software-operated portable laser unit, initiated by a ● footswitch similar delivery system comprising of an optical fiber, handpiece and single use disposable tips - . the same human factors of user interface Although some parameters such as maximum power output, power density, pulse rate differ among the devices, these differences do not result is a significantly different clinical performance since the settings and used for the expanded indications as well as the treatment regimen are essentially the same. Therefore, the consolidation of clinical applications creates no new risks or safety concerns. {7}------------------------------------------------ Companson of the technological characteristics, intended use, indications for use of the Epic 980 subject and predicate devices: | | Subject Device | Predicate Devices | | | | Reference Device | Pulse duration | 0.01 - 20 ms | 0.01 - 20 ms | 50, 30, 10ms | 0.01 – 0.99 s | variable | unknown | |--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|-------------------------------------------------------------------|-----------------------------------------------|-------------------------------------------------------|----------------------------------------------------------|--------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------| | Specification | Biolase Inc. Epic 980 | Biolase, Inc. Epic 980 (K192430) | QuickLase Limited QuickLase 980, 810 and Dual+ (K100474) | Sirona SIROLaser Advance (K103753) | Azena Medical, LLC Elumi 810 + 980 (K152032) | OroScience, Inc. Curative980 Diode Laser (K082445) | Spot size tips | 200 – 400 μm | 200 – 400 μm | 400 μm | 200 - 320 μm | 400 μm | unknown | | Laser medium | Solid state diode laser | Solid state diode laser | Solid state diode laser | Solid state diode laser | Solid state diode laser | Solid state diode laser | Power density | Up to 28294W/cm² | Up to 28294W/cm² | Up to 15915W/cm² | Up to 44563W/cm² | Up to 3138W/cm² | unknown | | Wavelength | 980 ±10 nm | 980 ±10 nm | 980 ± 10 nm, or 810 ± 10nm, or dual (810+980) | 970 ± 15nm | 980 ±10 nm, or 810 ± 10nm, or dual (810+980) | 980 ± 10 nm | Aiming beam | diode max 1mW 625 - 670 nm | diode max 1mW 625 - 670 nm | diode max 5mW 640 - 650nm | diode, max 1mW 635 - 650nm | diode max 5mW 640 - 660nm | diode 650nm | | | The devices cleared under K100474 and K152032 operate in 3 different wavelengths: 980nm alone, 810nm alone and dual (810+980nm). Biolase is claiming equivalence to the 980 nm version only. Therefore, substantially equivalent. | | | | | | Control panel | Touch screen | Touch screen | Touch screen | Touch screen | Touch screen | Touch screen | | Operating modes | Continuous, pulsed | Continuous, pulsed | Continuous, pulsed | Continuous, chopped(pulsed), peak pulse | Pulsed | Continuous, pulsed | Activation | Footswitch | Footswitch | Footswitch | Footswitch | Footswitch | Footswitch | | Max Power (CW) | 10 W | 10 W | 10W | 7W | 2W | 10 W | Delivery system | Fiber optic cable, handpiece and disposable tips | Fiber optic cable, handpiece and disposable tips | Quarts glass fiber | Fiber optic cable, handpiece and disposable tips | Quartz glass fiber and tips, handpiece and disposable tips | Optical fibers, handpieces and disposable tips | | | Although Epic 980 is capable of reaching 10W max power, the power settings used for all expanded indications do not exceed 1W, which is sufficient for effective performance and also falls under the maximum power of devices cleared under K103753 and K152032. Therefore, substantially equivalent. | | | | | | Fiber Tips | Quartz single-use tips varying in length and core diameter (200 - 400μm) | Quartz single-use tips varying in length and core diameter (200 - 400μm) | Fiber (400μm) | Single use tips varying in core diameter (200 - 320 μm) | Quarts tips (400μm) | Single use tips | | Max Peak Power | 10 W | 10 W | 10W @980, or 10W @810, or 20W @ dual | 14W | 10W @980, or 10W @810, or 20W @ dual | unknown | Materials | Medical grade plastics, stainless steel, aluminum, brass, and electronic parts and components | Medical grade plastics, stainless steel, aluminum, brass, and electronic parts and components | Medical grade plastics, stainless steel, and electronic parts and components | Medical grade plastics, stainless steel, and electronic parts and components | Medical grade plastics, stainless steel, and electronic parts and components | Medical grade plastics, stainless steel, and electronic parts and components | | Repetition rate (Frequency) | Up to 20 kHz | Up to 20 kHz | Up to 20 kHz | Up to 20 kHz | 50 Hz | unknown | | | | | | | | {8}------------------------------------------------ {9}------------------------------------------------ Intended use and Indications for Use | Epic 980 (subject device) | Epic 980 K192430 | QuickLase 810,980 & Dual+ K100474 | SiroLaser Advance K103753 | Elumi 810 + 980 K152032 | Curative 980 K082445 | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Dental soft tissue indications: incision, excision, vaporization, ablation and coagulation of oral soft-tissues including marginal and inter- dental gingival and epithelial lining of free gingiva and the following specific indications: | Dental soft tissue indications: Incision, excision, vaporization, ablation and coagulation of oral soft-tissues including marginal and inter- dental gingival and epithelial lining of free gingiva and the following specific indications: | Intended for incision, excision, vaporization, hemostasis and treatment of oral soft- tissue. Examples: | Indicated for intra and extraoral surgery including incision. excision, hemostasis, coagulation and vaporization of soft- tissues including marginal and inter- dental gingival and epithelial lining of free gingiva and is indicated for: | Soft tissue laser intended for the incision, excision, vaporization, hemostasis and treatment of oral soft- tissues. the following are the oropharyngeal indications for use: | Indicated for incision, excision, vaporization, ablation and coagulation of oral soft-tissues (intraoral and extraoral) including marginal and inter- dental gingival and epithelial lining of free gingiva and the following specific indications: | | excisional and incisional biopsies | excisional and incisional biopsies | excisional and incisional biopsies | biopsies | excisional and incisional biopsies | excisional and incisional biopsies | | exposure of unerupted teeth | exposure of unerupted teeth | exposure of unerupted teeth | exposure of unerupted/ partially erupted teeth | exposure of unerupted teeth | exposure of unerupted/ partially erupted teeth | | fibroma removal | fibroma removal | fibroma removal | fibroma removal | fibroma removal | fibroma removal | | frenectomy | frenectomy | frenectomy | frenectomy | frenectomy | frenectomy | | frenotomy | frenotomy | frenotomy | frenotomy | frenotomy | frenotomy | | gingival troughing for crown impressions | gingival troughing for crown impressions | gingival troughing for crown impressions | gingival troughing | gingival troughing for crown impressions | gingival troughing for crown impressions | | gingivectomy | gingivectomy | gingivectomy | gingivectomy | gingivectomy | gingivectomy | | gingivoplasty | gingivoplasty | gingivoplasty | gingivoplasty | gingivoplasty | gingivoplasty | | gingival incision and | gingival incision and | gingival incision and | gingival incision and | gingival incision and | gingival incision and | | excision | excision | excision | excision | excision | excision | | hemostasis and | hemostasis and | hemostasis and | hemostasis of donor | hemostasis and | hemostasis and | | coagulation | coagulation | coagulation | site | coagulation | coagulation | | implant recovery | implant recovery | implant recovery | implant recovery | implant recovery | implant recovery | | incision and drainage of | incision and drainage of | incision and drainage of | incision and drainage of | incision and drainage of | incision and drainage of | | abscess | abscess | abscess | abscess | abscess | abscess | | leukoplakia | leukoplakia | leukoplakia | leukoplakia | leukoplakia | leukoplakia | | operculectomy | operculectomy | operculectomy | operculectomy | operculectomy | operculectomy | | oral papillectomies | oral papillectomies | oral papillectomies | papillectomy | oral papillectomies | oral papillectomies | | pulpotomy | pulpotomy | pulpotomy | pulpotomy | pulpotomy | pulpotomy | | pulpotomy as an | pulpotomy as an | pulpotomy as an | pulpotomy as an | pulpotomy as an | pulpotomy as an | | adjunct to root canal | adjunct to root canal | adjunct to root canal | adjunct to root canal | adjunct to root canal | adjunct to root canal | | therapy | therapy | therapy | therapy | therapy | therapy | | reduction of gingival | reduction of gingival | reduction of gingival | reduction of gingival | reduction of gingival | reduction of gingival | | hypertrophy | hypertrophy | hypertrophy | hypertrophy | hypertrophy | hypertrophy | | soft-tissue crown | soft-tissue crown | soft-tissue crown | crown lengthening | soft-tissue crown | soft-tissue crown | | lengthening | lengthening | lengthening | | lengthening | lengthening | | treatment of canker | treatment of canker | treatment of canker | treatment of canker | treatment of canker | treatment of canker | | sores, herpetic and | sores, herpetic and | sores, herpetic and | sores, herpetic and | sores, herpetic and | sores, herpetic and | | aphthous ulcers of the | aphthous ulcers of the | aphthous ulcers of the | aphthous ulcers of the | aphthous ulcers of the | aphthous ulcers of the | | oral mucosa | oral mucosa | oral mucosa | oral mucosa | oral mucosa | oral mucosa | | vestibuloplasty | vestibuloplasty | vestibuloplasty | vestibuloplasty | vestibuloplasty | vestibuloplasty…